POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Device Facts
| Record ID | K133949 |
|---|---|
| Device Name | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Applicant | Top Calibre Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Apr 8, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Device Story
Ambidextrous, single-use, non-sterile nitrile examination gloves; available in blue or orange colors and five sizes (XS-XL). Designed to prevent cross-contamination between patient and examiner in medical/dental settings. Tested for permeation resistance against 15 specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection; healthcare providers wear gloves during patient examinations or procedures involving chemotherapy agents. Benefits include reduced risk of exposure to hazardous drugs and patient-to-examiner contamination.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on non-clinical bench testing, including physical properties (ASTM D6319-10), freedom from pinholes (ASTM D5151-11), powder residue (ASTM D6124-11), biocompatibility (ISO 10993-10:2010), and chemotherapy drug permeation (ASTM D6978-05).
Technological Characteristics
Nitrile material; ambidextrous design; non-sterile; powder-free. Complies with ASTM D6319-10 (dimensions, physical properties, powder residue) and ASTM D5151-11 (pinholes). Biocompatibility per ISO 10993-10:2010. Chemotherapy resistance tested per ASTM D6978-05.
Indications for Use
Indicated for use as a disposable patient examination glove for medical and dental purposes to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs-VBLU (K091652)
Submission Summary (Full Text)
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# APR 0 8 2014 K133949
# TOP CALIBRE SDN. BHD.
### FDA 510(k), Premarket Notification: 510(k) Summary
#### Date : April 01, 2014
#### 1.0 Submitter:
Top Calibre Sdn. Bhd. Lot 13726, Jalan Haji Salleh, Batu 5 1/4, Off Jalan Meru, 41050 Klang, Selangor, Malaysia
| Telephone No.: | +603 3291 0516 |
|----------------|----------------|
| Fax No.: | +603 3291 0542 |
#### 2.0 Contact Person:
| Contact: | Ms Rosnita Maodin |
|----------------|-------------------|
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0542 |
#### 3.0 Name of Device:
| Trade Name(s) | : Powder Free Nitrile Patient Examination Glove,<br>Blue Colored, Non-Sterile,<br>Tested for Use with Chemotherapy Drugs.<br>Powder Free Nitrile Patient Examination Glove,<br>Orange Colored, Non-Sterile,<br>Tested for Use with Chemotherapy Drugs. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Powder-Free Nitrile Patient Examination Glove |
| Classification Name | : Patient Examination Glove |
| Regulation Number | : 21 CFR 880.6250 |
| Classification Number | : Class I |
| Product Code | : 80 LZA, 80 LZC |
#### 4.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, Class I Patient Examination Gloves, Nitrile - 80 LZA, Specialty - 80 LZC, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K091652, Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs-VBLU
Page 1 of 9 (Rev 3)
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There are no different technological characteristics compared to the Predicate Device.
#### 5.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10.
The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
#### Intended Use of the Device: 6.0
- Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-6. I Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
# Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---------------------------------------|------|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
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- Device Name: Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-6.2 Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
# Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---------------------------------------|------|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
# Please note that the following drug - Carmustine has extremely short permeation times of 17.9 minutes.
#### 7.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs posses the following technological characteristic (as compared to ASTM or equivalent standards):
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| Characteristic | Standards<br>Requirements | Results Summary | Conclusions | | | | | | | | | |
|----------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|-----------------------------------|
| Dimensions | ASTM D6319-10 | Length ≥ 270mm<br>Palm Thickness ≥ 0.10mm<br>Finger Thickness ≥ 0.10mm<br>Width<br>X-Small 70-80mm<br>Small 80-90mm<br>Medium 90-100mm<br>Large 101-111mm<br>X-Large ≥ 111mm | Meets<br>Standard<br>Requirements | | | | | | | | | |
| Physical<br>Properties | ASTM D6319-10 | Before Aging After Aging Tensile Strength ≥ 14 MPA ≥ 14 MPA Elongation > 500% > 400% | | | | | | | | | | Meets<br>Standard<br>Requirements |
| | | | | | | | | | | | | |
| Freedom from<br>pinholes | ASTM D5151-11<br>ASTM D6319-10 | Tested in accordance with ASTM D5151 test<br>method. Pass quality level at G1 AQL 1.5 | Meets<br>Standard<br>Requirements | | | | | | | | | |
| Powder Free<br>Residue | ASTM D6124-11<br>ASTM D6319-10 | Result generated values ≤ 2 mg of residual powder<br>per glove | Meets<br>Standard<br>Requirements | | | | | | | | | |
| Biocompatibility | Dermal Sensitization<br>(as ISO 10993-<br>10:2010) | Not a contact skin sensitizer | Meets<br>Standard<br>Requirements | | | | | | | | | |
| | Primary Skin Irritation<br>Test (as ISO 10993-<br>10:2010) | Not a primary skin irritant | | | | | | | | | | |
| | | | | | | | | | | | | |
| Chemotherapy<br>Drugs<br>Permeation Test<br>Method | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,<br>Blue Colored, Non-Sterile, Tested for Use with<br>Chemotherapy Drugs<br><br>Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection Time in Minutes) | Tested for Use<br>with<br>Chemotherapy<br>Drugs.<br>Carmustine<br>has extremely<br>short<br>permeation<br>times of 15.1<br>minutes. | | | | | | | | | |
| | | Carmustine (3.3 mg/ml) 15.1<br>Cisplatin (1.0 mg/ml) >240<br>Cyclophosphamide (20 mg/ml) >240<br>Cytarabine (100 mg/ml) >240<br>Dacarbazine (DTIC) (10.0 mg/ml) >240<br>Doxorubicin Hydrochloride (2.0 mg/ml) >240<br>Etoposide (20.0 mg/ml) >240<br>Fluorouracil (50.0 mg/ml) >240<br>Ifosfamide (50.0 mg/ml) >240<br>Methotrexate (25 mg/ml) >240<br>Mitomycin C (0.5 mg/ml) >240<br>Mitoxantrone (2.0 mg/ml) >240<br>Paclitaxel (Taxol) (6.0 mg/ml) >240<br>Thiotepa (10.0 mg/ml) >240<br>Vincristine Sulfate (1.0 mg/ml) >240 | | | | | | | | | | |
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| Characteristic | Standards<br>Requirements | Results Summary | Conclusions |
|----------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Chemotherapy<br>Drugs<br>Permeation Test<br>Method | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,<br>Orange Colored, Non-Sterile, Tested for Use with<br>Chemotherapy Drugs | |
| | | Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection Time in Minutes) | Tested for Use<br>with |
| | | Carmustine (3.3 mg/ml) | 17.9 |
| | | Cisplatin (1.0 mg/ml) | >240 |
| | | Cyclophosphamide (20 mg/ml) | >240 |
| | | Cytarabine (100 mg/ml) | >240 |
| | | Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| | | Etoposide (20.0 mg/ml) | >240 |
| | | Fluorouracil (50.0 mg/ml) | >240 |
| | | Ifosfamide (50.0 mg/ml) | >240 |
| | | Methotrexate (25 mg/ml) | >240 |
| | | Mitomycin C (0.5 mg/ml) | >240 |
| | | Mitoxantrone (2.0 mg/ml) | >240 |
| | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| | | Thiotepa (10.0 mg/ml) | >240 |
| | | Vincristine Sulfate (1.0 mg/ml) | >240 |
| | | | Chemotherapy<br>Drugs.<br>Carmustine<br>has extremely<br>short<br>permeation<br>times of 17.9<br>minutes. |
#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no difference between the Proposed Devices and the Predicate Device with respect to performance standard and technological characteristics.
There is difference in colorant used in one of the Proposed Device (Orange), compared with Predicate Device (Blue). However, the difference does not affect the safety and effectiveness of the Proposed Device (Orange), as the Proposed Device (Orange) tested and passed Biocompatibility test, similar with Predicate Device.
The Proposed Devices were tested for 15 drugs, while the Predicate Device was tested for 12 drugs. The respective drug's permeation result is shown in Indication for Use of the Proposed Devices. The difference in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use do not affect the safety and effectiveness of the proposed devices.
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#### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
#### 10.0 Conclusion
It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs are substantially equivalent to the predicate device identified in this 510(k) summary.
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed devices and the predicate device for the substantial equivalent determination.
As such, this device is substantially equivalent to predicate device.
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# Substantial Equivalent Comparison Table
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| ics | Predicate Device | Proposed Device (Blue) | Predicate Device | Proposed Device (Orange) | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested<br>for Use with Chemotherapy<br>Drugs-VBLU | Powder Free Nitrile Patient<br>Examination Glove, Blue<br>Colored, Non-Sterile, Tested for<br>Use with Chemotherapy Drugs | K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested<br>for Use with Chemotherapy<br>Drugs-VBLU | Powder Free Nitrile Patient<br>Examination Glove, Orange<br>Colored, Non-Sterile, Tested for<br>Use with Chemotherapy Drugs | |
| cription/<br>umber | Patient Examination Glove/<br>21 CFR Part 880.6250 | Substantial Equivalent | Patient Examination Glove/<br>21 CFR Part 880.6250 | Substantial Equivalent | |
| | 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | |
| | Intended for medical and dental<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Substantial Equivalent | Intended for medical and dental<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Substantial Equivalent | |
| Characteristics | Predicate Device<br>K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested for<br>Use with Chemotherapy Drugs-VBLU | | Proposed Device (Blue)<br>Powder Free Nitrile Patient<br>Examination Glove, Blue Colored,<br>Non-Sterile, Tested for Use with<br>Chemotherapy Drugs | Predicate Device<br>K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested for<br>Use with Chemotherapy Drugs-VBLU | Proposed Device (Orange)<br>Powder Free Nitrile Patient<br>Examination Glove, Orange Colored,<br>Non-Sterile, Tested for Use with<br>Chemotherapy Drugs |
| Indications for Use | The Nitrile Examination Glove (Tested<br>for Use with Chemotherapy Drugs) is a<br>disposable device intended for medical<br>and dental-purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. The list of chemotherapy<br>drugs tested (with breakthrough times)<br>are as follows:- | | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner.<br>This glove has been tested for use<br>with specific chemotherapy drugs<br>listed below. | The Nitrile Examination Glove<br>(Tested for Use with Chemotherapy<br>Drugs) is a disposable device intended<br>for medical and dental purposes that is<br>worn on the examiner's hand to<br>prevent contamination between patient<br>and examiner. The list of<br>chemotherapy drugs tested (with<br>breakthrough times) are as follows:- | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner.<br>This glove has been tested for use<br>with specific chemotherapy drugs<br>listed below. |
| | | | Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection<br>Time in Minutes) | Chemotherapy Drugs<br>Breakthrough Time (Minutes) | Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection<br>Time in Minutes) |
| | | | Carmustine (3.3 mg/ml) | Carmustine | 6.60 |
| | | | Cisplatin (1.0 mg/ml) | Cisplatin | >240 |
| | | | Cyclophosphamide<br>(20mg/ml) | Cyclophosphamide (Cytoxan) | >240 |
| | | | Cytarabine (100 mg/ml) | Dacarbazine | >240 |
| | | | Dacarbazine (DTIC)<br>(10.0 mg/ml) | Doxorubicin Hydrochloride | >240 |
| | | | Doxorubicin Hydrochloride<br>(2.0 mg/ml) | Etoposide | >240 |
| | | | Etoposide (20.0 mg/ml) | Fluorouracil | >240 |
| | | | Fluorouracil (50.0 mg/ml) | Methotrexate | >240 |
| | | | Ifosfamide (50.0 mg/ml) | Mitomycin C | >240 |
| | | | Methotrexate (25 mg/ml) | Paclitaxel | >240 |
| | | | Mitomycin C (0.5 mg/ml) | Thiotepa | 14.83 |
| | | | Mitoxantrone (2.0 mg/ml) | Vincristine Sulfate | >240 |
| | | | Paclitaxel (Taxol) (6.0 mg/ml) | Warning: Do not use with<br>Carmustine and Thiotepa. | |
| | | | Thiotepa (10.0 mg/ml) | | |
| | | | Vincristine Sulfate (1.0 mg/ml) | | |
| | Please note that the following drug<br>- Carmustine has extremely short<br>permeation times of 17.9 minutes. | | | | |
Page 7 of 9 (Rev 3)
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Page 8 of 9 (Rev 3)
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| Characteristics | Predicate Device<br>K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested<br>for Use with Chemotherapy<br>Drugs-VBLU | Proposed Device (Blue)<br>Powder Free Nitrile Patient<br>Examination Glove, Blue<br>Colored, Non-Sterile, Tested for<br>Use with Chemotherapy Drugs<br>Substantial Equivalent | Predicate Device<br>K091652 Nitrile Powder Free<br>Examination Gloves (Blue) Tested<br>for Use with Chemotherapy<br>Drugs-VBLU | Proposed Device (Orange)<br>Powder Free Nitrile Patient<br>Examination Glove, Orange<br>Colored, Non-Sterile, Tested for<br>Use with Chemotherapy Drugs<br>Substantial Equivalent |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Nitrile | Substantial Equivalent | Nitrile | Substantial Equivalent |
| Color | Blue | Substantial Equivalent | Blue | Orange |
| Design | Ambidextrous, in different sizes<br>per ASTM D6319 dimension<br>requirement. | Substantial Equivalent | Ambidextrous, in different sizes<br>per ASTM D6319 dimension<br>requirement. | Substantial Equivalent |
| Performance<br>I. Sterility | Not Applicable (Non-Sterile) | Substantial Equivalent | Not Applicable (Non-Sterile) | Substantial Equivalent |
| II. Freedom from<br>holes | Passes at AQL 1.5 | Passes at AQL 1.5 (Substantial<br>Equivalent) | Passes at AQL 1.5 | Passes at AQL 1.5 (Substantial<br>Equivalent) |
| III. Dimension | Meets ASTM D6319 | Meets ASTM D6319 (Substantial<br>Equivalent) | Meets ASTM D6319 | Meets ASTM D6319 (Substantial<br>Equivalent) |
| IV. Physical<br>Properties | Meets ASTM D6319 | Meets ASTM D6319 (Substantial<br>Equivalent) | Meets ASTM D6319 | Meets ASTM D6319 (Substantial<br>Equivalent) |
| V. Powder Free<br>Residue | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (Substantial<br>Equivalent) | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (Substantial<br>Equivalent) |
| Single Use | Yes | Substantial Equivalent | Yes | Substantial Equivalent |
| Biocompatibility<br>Test | Passes<br>i. Primary Skin Irritation Test<br>ii. Dermal Sensitization Test | Not an irritant<br>Not a contact sensitizer | Passes<br>i. Primary Skin Irritation Test<br>ii. Dermal Sensitization Test | Not an irritant<br>Not a contact sensitizer |
| Packaging | Packed in Dispenser Boxes | Substantial Equivalent | Packed in Dispenser Boxes | Substantial Equivalent |
| Labeling Claim | Tested For Use with<br>Chemotherapy Drugs | Substantial Equivalent | Tested For Use with<br>Chemotherapy Drugs | Substantial Equivalent |
Page 9 of 9 (Rev 3)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 8, 2014
Top Calibre Sdn. Bhd. Ms. Rosnita Maodin Quality Assurance Manager Lot 13726, Jalan Haji Salleh, Batu 5 ¼ , Off Jalan Meru Klang, Selangor MALAYSIA 41050
Re: K133949
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-sterile, Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 3, 2014 Received: March 6, 2014
Dear Ms. Maodin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Maodin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 t CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breaktbrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---------------------------------------|-------|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (2) CFR 801 Subpan C) x
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
# Elizabeth F. Claverie -S 2014.04.07 23:45:16 -04'00'
Page 1 of _
{12}------------------------------------------------
# Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---------------------------------------|-------|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drug . Carmustine has extremely short permeation times of 17,9 minutes.
× AND/OR Prescription Use Over-The-Counter Use (Part 2) CFR 801 Subpart D) (2) CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
# Elizabeth F. Claverie -S 2014.04.07 23:46:05 -04'00'
Page I of .
