Who is the manufacturer of MULTIPLE NAME?

Top Calibre Sdn Bhd filed the 510(k) submission for MULTIPLE NAME (K123819).

What is the FDA product code for MULTIPLE NAME?

LYY. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for MULTIPLE NAME?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MULTIPLE NAME?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTIPLE NAME

K123819 · Top Calibre Sdn Bhd · LYY · Mar 5, 2013 · General Hospital

Device Facts

Record ID	K123819
Device Name	MULTIPLE NAME
Applicant	Top Calibre Sdn Bhd
Product Code	LYY · General Hospital
Decision Date	Mar 5, 2013
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

Disposable, non-sterile, ambidextrous natural rubber latex patient examination glove; available in sizes XS-XL. Designed to prevent cross-contamination between patient and examiner. Tested for permeation resistance against 15 specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is a physical barrier; healthcare providers use the glove to protect themselves from patient bodily fluids and chemotherapy agents. Benefits include reduced risk of contamination and exposure to hazardous drugs.

Clinical Evidence

Bench testing only. No clinical data required for examination gloves. Performance verified via ASTM D3578-05 (dimensions, physical properties), ASTM D5151-11 (pinholes), ASTM D6124-11 (powder residue), ASTM D5712-10 (protein content), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (dermal sensitization and primary skin irritation).

Technological Characteristics

Material: Natural rubber latex. Form: Ambidextrous, powder-free, non-sterile. Standards: ASTM D3578-05 (2010), ASTM D5151-11, ASTM D6124-11, ASTM D5712-10, ASTM D6978-05. Protein content: ≤ 50 µg/dm². Powder residue: ≤ 2 mg/glove. Biocompatibility: Non-sensitizing, non-irritant per ISO 10993-10.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs; users should note short permeation times for Carmustine (15.4 min) and Thiotepa (30.6 min).

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

Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (K083409)

Submission Summary (Full Text)

{0}------------------------------------------------ # K123819 MAR 0 5 2013 ### FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information ### Date: 01 March 2013 #### 1.0 Submitter: Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, 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: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein) Common Name : Patient Examination Glove Classification Name : Patient Examination Glove Regulation Number : 21 CFR 880.6250 Classification Number: Class I Product Code : 80 LYY, 80 LZC #### 4.0 Identification of the Legally Marketed Device: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80 LY Y, Specialty - 80 LZC, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove. Predicate Device: K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50 ug/dm2 per glove of Extractable Protein). Page 1 of 7 (Rev 3) {1}------------------------------------------------ #### 5.0 Description of Device: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL). #### 6.0 Intended Use of the Device: 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) | 15.4 | |-----------------------------------------|-------| | Cisplatin (1.0 mg/ml) | > 240 | | Cyclophosphamide (Cytoxan) (20.0 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) | 30.6 | | Vincristine Sulfate (1.0 mg/ml) | > 240 | Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively. {2}------------------------------------------------ #### 7.0 Summary of the Technological Characteristics of the Device: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards): | Characteristic | Standards Requirements | Results Summary | Conclusions | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimensions | ASTM D 3578-05 (2010) | Length ≥ 270mm Palm Thickness ≥ 0.20mm Finger Thickness ≥ 0.25mm Width X-Small 70-80mm Small 80-90mm Medium 90-100mm Large 101-111mm X-Large ≥ 111mm | Meets Standard Requirements | | Physical Properties | ASTM D 3578-05 (2010) | Before Aging After Aging Tensile Strength ≥ 18 MPA ≥ 14 MPA Elongation ≥ 650% ≥ 500% | Meets Standard Requirements | | Freedom from pinholes | ASTM D 5151-11 ASTM D 3578-05 (2010) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Meets Standard Requirements | | Powder Free Residue | ASTM D 6124-11 ASTM D 3578-05 (2010) | Result generated values ≤ 2 mg of residual powder per glove | Meets Standard Requirements | | Protein Content | ASTM D 5712-10 ASTM D 3578-05 (2010) | Result generated values ≤ 50 microgram/dm2 | Meets Standard Requirements | | Biocompatibility | Dermal Sensitization (as ISO 10993- 10:2010) Primary Skin Irritation Test (as ISO 10993- 10:2010) | Not a contact skin sensitizer Not a primary skin irritant | Meets Standard Requirements | | Chemotherapy Drugs Permeation Test Method | ASTM D6978-05 | Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) Carmustine (3.3 mg/ml) 15.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 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) 30.6 Vincristine Sulfate (1.0 mg/ml) >240 | Tested for Use with Chemotherapy Drugs. Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively. | Page 3 of 7 (Rev 3) {3}------------------------------------------------ #### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein) has been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards. There is no different between the proposed device and the predicate with respect to performance standard and technological characteristics. The predicate device was tested for nine drugs, while proposed device tested for 15 drugs. Respective drug's permeation result is shown in Indication for Use of the proposed device. The different in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use (with permeation results added) does not affect the safety and effectiveness of the proposed device. ### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for market cleared examination gloves. #### 10.0 Conclusion It can be concluded that the Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein), is as safe and effective as, the current legally marketed device identified in this 510(k) summary. The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination. The gloves are Substantial Equivalent to predicate device cleared under 510(k) K083409. {4}------------------------------------------------ ### Substantial Equivalent Comparison Table | Characteristics | Predicate Device | Proposed Device | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim ( $≤50 ug/dm²$ per glove of Extractable Protein) | Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm² of glove or less of Water Extractable Protein) | | Device Description/ Regulation Number | Patient Examination Glove/ 21 CFR Part 880.6250 | Substantial Equivalent | | Product Code | 80 LYY, 80 LZC | Substantial Equivalent | | Intended Use | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Substantial Equivalent | | Characteristics | Predicate Device | Proposed Device | | | K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50 ug/dm² per glove of Extractable Protein) | Powder Free Latex Patient Examination Glove, Blue, with Protein Content and Chemotherapy Drugs Labeling Claim (Contains 50 Micrograms per dm² of glove or less of Water Extractable Protein) | | Indications for Use | The powder free chemotherapy examination glove is a specialty medical. glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste and environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] Warning: Do not use gloves with Thio-tepa and Carmustine. | 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 (3.3 mg/ml) 15.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 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) 30.6 Vincristine Sulfate (1.0 mg/ml) >240 Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively. | | Design | Ambidextrous, in different sizes per ASTM D3578 dimension requirement | Substantial Equivalent | | Characteristics | Predicate Device | Proposed Device | | Materials | Natural Rubber Latex | Substantial Equivalent | | Color | Blue | Substantial Equivalent | | Performance I. Sterility II. Freedom from holes III. Dimension IV. Physical Properties V. Powder Free Residue VI. Protein Content | K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim ( $\leq$ 50 ug/dm² per glove of Extractable Protein) | Powder Free Latex Patient Examination Glove, Blue, with Protein Content and Chemotherapy Drugs Labeling Claim (Contains 50 Micrograms per dm² of glove or less of Water Extractable Protein) | | | Not Applicable (Non-Sterile) Passes at AQL 1.5 Meets ASTM D3578 Meets ASTM D3578 Meets $\leq$ 2 mg/glove Meets $\leq$ 50 $\mu$ g/dm² | Substantial Equivalent Passes at AQL 1.5 (Substantial Equivalent) Meets ASTM D3578 (Substantial Equivalent) Meets ASTM D3578 (Substantial Equivalent) Meets $\leq$ 2 mg/glove (Substantial Equivalent) Meets $\leq$ 50 $\mu$ g/dm² (Substantial Equivalent) | | Single Use | Yes | Substantial Equivalent | | Biocompatibility Test | Passes. i. Primary Skin Irritation Test ii. Dermal Sensitization Test | Substantial Equivalent Substantial Equivalent | | Packaging | Packed in Dispenser Boxes | Substantial Equivalent | | Labeling Claim | i. With Extractable Protein Content Labeling Claim ii. Chemotherapy Drugs Labeling Claim per ASTM D6978-05 | Substantial Equivalent | - {5}------------------------------------------------ · . {6}------------------------------------------------ . : · . {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5, 2013 Ms. Rosnita Maodin Quality Assurance Manager Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13 Shah Alam, Selangor Malaysia 40170 Re: K123819 Trade/Device Name: Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY, LZC Dated: January 30, 2013 Received: February 4, 2013 Dear Ms. Moadin: 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. Iisting 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. {8}------------------------------------------------ ### 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 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/8/Picture/6 description: The image shows a logo or emblem with stylized text and geometric shapes. The text appears to be handwritten and somewhat illegible, possibly reading "For" at the top left, with other words like "with" and "without" incorporated into the design. The geometric shapes include a maze-like pattern on the left and a triangular structure on the right, giving the logo a complex and abstract appearance. The overall design is black and white and has a rough, hand-drawn quality. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Device Name: Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) ### 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. K123819 ### Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) | Carmustine (BCNU) (3.3 mg/ml) | 15.4 | |-----------------------------------------|-------| | Cisplatin (1.0 mg/ml) | > 240 | | Cyclophosphamide (Cytoxan) (20.0 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) | 30.6 | | Vincristine Sulfate (1.0 mg/ml) | > 240 | Please note that the following drugs - Carnustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 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 | | |-----------------------------|--| | Claverie | | | 2013.03.05 16:12:07 -05'00' | | (Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices 510(k) Number: K123819 Page I of ਮ

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Submission Summary (Full Text)

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