Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
Device Facts
| Record ID | K232252 |
|---|---|
| Device Name | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
| Applicant | Dehai (Shandong) Medical Gloves, Co., Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Nov 28, 2023 |
| 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 or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Story
Disposable, non-sterile, powder-free nitrile examination gloves; available in black and orange. Worn by healthcare professionals during patient examinations to provide a barrier against contamination. Tested per ASTM D6978-05 for permeation resistance against specific chemotherapy drugs and fentanyl citrate. Output is a physical barrier; clinical decision-making is unaffected by the device itself, but the barrier protects the clinician from exposure to hazardous drugs and patient contaminants. Benefits include reduced risk of cross-contamination and protection during handling of chemotherapy agents.
Clinical Evidence
Bench testing only. No clinical data. Testing included physical properties (tensile strength, elongation), dimensions, freedom from holes (ASTM D5151-19), residual powder content (ASTM D6124-06), and permeation testing against chemotherapy drugs (ASTM D6978-05). Biocompatibility testing included primary skin irritation (ISO 10993-23), skin sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). All results met acceptance criteria.
Technological Characteristics
Material: Nitrile synthetic rubber latex. Design: Powder-free, non-sterile, ambidextrous, beaded cuff. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D6978-05 (chemo permeation), ASTM D5151-19 (leak test), ASTM D6124-06 (powder residue). Biocompatibility: ISO 10993-10, 10993-11, 10993-23. Dimensions: Length 220-230mm min, thickness 0.05mm min. Connectivity: None.
Indications for Use
Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs and fentanyl citrate. Contraindicated for use with Carmustine and Thiotepa due to low permeation times.
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 EXAMINATIONGLOVES POWDERFREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE(BLUE & BLACK) (K230121)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 28, 2023
Dehai (Shandong) Medical Gloves, Co., Ltd. % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario, California 91764
#### Re: K232252
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: October 26, 2023 Received: October 30, 2023
Dear Deze Wang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Ouality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
# Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K232252
#### Device Name
Nittile Powder Free Examination Gloves Tested for Use with Chemotherapy Drues and Fentaxy, Citrate (Black), Nittle Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange).
#### Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs and Fentanyl<br>Concentration | | Minimum Breakthrough Detection Time (minutes) | |
|------------------------------------------------------------------------|-----------------------|-----------------------------------------------|-----------|
| | | Black | Orange |
| *Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| *Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| *Please note that following drugs have extremely low permeation times: | | | |
| 1. Carmustine (BCNU) | | | |
| 2. Thio Tepa | | | |
| Warning: Do not use with Carmustine and Thiotepa | | | |
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(K) SUMMARY K232252
(As requirement by 21 CFR 807.92)
| Applicant Name | Dehai (Shandong) Medical Gloves, Co., Ltd. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Location | No. 216 Huagong Road Linzi District, Zibo City,<br>Shandong Province, China |
| Contact Person: | Li xiaomeng |
| Tel: | +86-13917372099 |
| Date summary prepared: | 16th Nov. 2023<br>Device Information |
| Trade Name: | Nitrile Powder Free Examination Gloves Tested for Use with Ch |
| Trade Name: | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy<br>Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves<br>Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
| Common Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification Name: | Non-Powdered Patient Examination Gloves |
| Product Code: | LZA, LZC, QDO, OPJ |
| Regulation: | 21CFR:880, 6250 |
#### Predicate Device
NITRILE EXAMINATIONGLOVES POWDERFREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE(BLUE & BLACK), 510(K) number K230121 product code LZA, LZC, QDO, OPJ.
#### Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large. The Nitrile Examination Gloves Powder Free (Black & Orange) have been tested for Chemotherapy Drugs and Fentanyl Citrate as below:
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## DH Medical
| Chemotherapy Drugs and<br>Fentanyl | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|-------------------------------------------------------------------------|-----------------------|-----------------------------------------------|-----------|
| | | Black | Orange |
| * Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| * Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| * Please note that following drugs have extremely low permeation times: | | | |
| 1. Carmustine (BCNU) | | | |
2. Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
#### Indications for Use
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 ( Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs<br>and Fentanyl | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|-------------------------------------------------------------------------|-----------------------|-----------------------------------------------|-----------|
| | | Black | Orange |
| * Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| * Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| * Please note that following drugs have extremely low permeation times: | | | |
1 . Carmustine ( BCNU)
2. Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
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#### Summary of The Technological Characteristic
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange), are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Subject Device<br>K232252 | Predicate Device<br>K230121 | Remarks | |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same | |
| Intended Use | - | Intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner | Intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner | Same | |
| Design | - | Powder Free, Non-Sterile,<br>Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile,<br>Ambidextrous, Beaded Cuff | Same | |
| Indications for<br>Use | - | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with Chemotherapy<br>Drugs and Fentanyl Citrate as<br>per ASTM D6978-05<br>(Reapproved 2019) Standard<br>Practice for Assessment of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with Chemotherapy<br>Drugs and Fentanyl Citrate<br>as per ASTM D6978-05<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | Same | |
| Construction | - | Ambidextrous Chlorinated,<br>Powder Free Nitrile | Ambidextrous, Polymer<br>Coated or Chlorinated,<br>Powder Free Nitrile | Similar | |
| Color Description | - | Black & Orange | Blue & Black | Different | |
| Material | - | Nitrile | Nitrile | Similar | |
| Single Use | - | Yes | Yes | Same | |
| Packaging | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same | |
| Chemo Drugs<br>Claim | - | Chemo Drugs & Fentanyl<br>Citrate claim | Chemo Drugs & Fentanyl<br>Citrate claim | Similar | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Dimension | - | | | | |
| Length<br>S, M, L, XL, XXL | ASTM D6319- 19 | Meet 220mm min for S<br>Meet 230mm min for other sizes | Meet 220mm min for small<br>Meet 230mm min for other sizes | Similar | |
| Thickness (palm),<br>Thickness (finger), | - | Meet 0.05mm min<br>Meet 0.05mm min | Meet 0.05mm min<br>Meet 0.05mm min | Similar | |
| Width | - | S: Meet $80 \pm 10$ mm<br>M: Meet $95 \pm 10$ mm<br>L: Meet $110 \pm 10$ mm<br>XL: Meet $120 \pm 10$ mm<br>XXL: Meet $130 \pm 10$ mm | S: Meet $80 \pm 10$ mm<br>M: Meet $95 \pm 10$ mm<br>L: Meet $110 \pm 10$ mm<br>XL: Meet $120 \pm 10$ mm | Similar | |
| Characteristic | Standard | Subject Device<br>K232252 | Predicate Device<br>K230121 | Remarks | |
| Physical Properties | | | | | |
| (Before Ageing)<br>i) Tensile Strength<br>(MPa)<br>ii) Ultimate<br>Elongation (%) | ASTM D6319- 19 | Meet 14MPa min.<br>Meet 500% min | Meet 14MPa min.<br>Meet 500% min | Same | |
| (After Aging)<br>i) Tensile Strength<br>(MPa)<br>ii) Ultimate<br>Elongation (%)<br>Water Leak Test, | | Meets 14MPa min<br>Meet 400% min. | Meets 14MPa min<br>Meet 400% min. | Same | |
| 1000 ml<br>Before Aging, AQL | ASTM D6319- 19<br>ASTM D5151-19 | Passes at AQL 2.5<br>Meet the ASTM D<br>6319-19 requirement | Passes at AQL 1.5 | Different | |
| Powder Free<br>Residue<br>Powder Free | ASTM D6319- 19<br>ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max. | Same | |
| Residue, mg/ glove | | | | | |
| Biocompatibility<br>Test | | | | | |
| i) Primary Skin<br>Irritation Test | ISO 10993-23 new<br>version<br>(ISO 10993- 10) | Passes<br>Conclusion: The test result<br>showed that the response of<br>the test article was<br>categorized as negligible<br>under the test condition | Passes<br>Conclusion: Under the<br>conditions of this study the<br>test material did not cause an<br>irritant response | Similar | |
| ii) Skin Sensitization<br>Test | ISO 10993- 10 | Passes<br>Conclusion: Under the<br>conditions of this study, the test<br>article showed no significant<br>evidence of causing skin<br>sensitization in the guinea pig | Passes<br>Conclusion: Under the<br>conditions of this study, the<br>test material did not produce a<br>skin sensitization effect | Similar | |
| iii) Acute<br>Systemic Toxicity | ISO 10993- 11 | Conclusion: Under the<br>conditions of this study, there<br>was no evidence of acute<br>systemic toxicity from the<br>extract. The test article extract<br>met the requirements of the<br>study. | Conclusion: Under the<br>conditions of this study, the<br>test material showed no<br>adverse biological reaction<br>after administration of the<br>sample's extract on the rats<br>during the period of the<br>study. | Similar | |
| Black color | | | | | |
| Test | Method | Acceptance Criteria | Result | | |
| Freedom From<br>Holes | ASTM<br>D6319-19<br>ASTM<br>D5151-19 | Meet requirement inspection level<br>G- 1, AQL 2.5<br>Sampling size125pcs(Ac: 7,Re: 8) | Pass<br>≤3pcs | | |
| Dimension | ASTM<br>D6319-19 | Length<br>220 mm min (small)<br>230 mm min (other sizes)<br>Width(mm)<br>S: 80±10<br>M: 95±10<br>L : 110±10<br>XL : 120±10<br>XXL : 130±10<br>Thickness(mm):<br>Palm: Minimum 0.05<br>Finger: Minimum 0.05 | Pass<br>241 mm min<br>Pass<br>S: average 85.5mm<br>M: average 96.3mm<br>L: average 106.4mm<br>XL: average 115.5mm<br>XXL: average 125.1mm<br>Pass<br>Palm - 0.178mm min.<br>Finger-0.199mm min | | |
| Physical<br>properties | ASTM<br>D6319-19 | Before Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 500%, min.<br>After Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 400%, min. | Pass<br>Before Aging:<br>Tensile Strength: 15.1 MPa, min.<br>Elongation: 518%, min.<br>After Aging:<br>Tensile Strength: 15.0MPa, min.<br>Elongation: 460%, min. | | |
| Residual<br>Powder Content | ASTM<br>D6319-19<br>ASTM<br>D6124-06 | Not more than 2 mg per glove | Pass<br>average 0.32mg | | |
| Biocompatibility<br>i) Primary Skin<br>Irritation<br>ii) Skin<br>Sensitization<br>iii) Acute<br>Systemic<br>Toxicity | ISO 10993-23<br>ISO 10993-10<br>ISO 10993-11 | Not a primary skin irritant<br>Not a contact sensitizer<br>No systemic toxicity | Pass<br>Pass<br>Pass | | |
| Chemotherapy<br>Drug | Concentration | Minimum Breakthrough Detection<br>Time (minutes) | Remark | | |
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#### Summary of Non-Clinical Testing
Following is a table showing the actual measured parameters of the gloves (e.g length, thickness, physical properties, etc.) as compared to ASTM, EN and ISO. All data meets the standard reference requirement.
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# DH Medical
| Orange color | | | |
|---------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Method | Acceptance Criteria | Result |
| Freedom From<br>Holes | ASTM<br>D6319-19<br>ASTM<br>D5151-19 | Meet requirement inspection level<br>G- 1, AQL 2.5<br>Sampling size125pcs(Ac: 7,Re: 8) | Pass<br>≤4pcs |
| Dimension | ASTM<br>D6319-19 | Length<br>220 mm min (small)<br>230 mm min (other sizes)<br>Width(mm)<br>S: 80±10<br>M: 95±10<br>L : 110±10<br>XL : 120±10<br>XXL : 130±10<br>Thickness(mm):<br>Palm:Minimum 0.05<br>Finger:Minimum 0.05 | Pass<br>240 mm min<br>Pass<br>S: average 85.8mm<br>M: average 96.1mm<br>L: average 106.8mm<br>XL: average 115.9mm<br>XXL: average 125.6mm<br>Pass<br>Palm - 0.181mm min.<br>Finger-0.212mm min |
| Physical<br>properties | ASTM<br>D6319-19 | Before Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 500%, min.<br>After Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 400%, min. | Pass<br>Before Aging:<br>Tensile Strength: 15.3 MPa, min.<br>Elongation: 502%, min.<br>After Aging:<br>Tensile Strength: 14.1MPa, min.<br>Elongation: 462%, min. |
| Residual<br>Powder Content | ASTM<br>D6319-19<br>ASTM<br>D6124-06 | Not more than 2 mg per glove | Pass<br>average 0.30mg |
| Biocompatibility | i) Primary Skin<br>Irritation | ISO 10993-23<br>Not a primary skin irritant | Pass |
| | ii) Skin<br>Sensitization | ISO 10993-10<br>Not a contact sensitizer | Pass |
| | iii) Acute<br>Systemic<br>Toxicity | ISO 10993-11<br>No acute systemic toxicity | Pass |
| Chemotherap<br>y Drug and<br>Fentanyl | Concentration | Minimum Breakthrough Detection<br>Time (minutes) | Remark |
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| | | Proposed Device | | Predicate Device | | |
|----------------------|------------|-----------------------------------------------------------------------------|----------|------------------------------------------------------------------------------|----------|-----------|
| | | Black | Orange | Blue | Black | |
| * Carmustine ( BCNU) | 3.3 mg/ml | 21.6 | 22.7 | 22.6 | 21.8 | Different |
| Cyclophosphamide | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Etoposide | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| * Thio Tepa | 10.0 mg/ml | 28 | 37.1 | 43.9 | 17.7 | Different |
| Mitomycin C | 0.5mg/ml | >240 min | >240 min | Not test | Not test | Different |
| Oxaliplatin | 5mg/ml | >240 min | >240 min | Not test | Not test | Different |
| Dacarbazine | 10.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Ifosfamide | 50.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Cisplatin | 1.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Mitoxantrone | 2 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Vincristine Sulfate | 1.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min | >240 min | >240 min | Same |
| Warning | | Please note that following<br>drugs have extremely low<br>permeation times: | | *Please note that following<br>drugs have extremely low<br>permeation times: | | Similar |
| | | 1. Carmustine (BCNU) (3.3 mg/ml) | | 1. Carmustine (BCNU) (3.3 mg/ml) | | |
| | | 2. Thio Tepa (10 mg/ml) | | 2. Thio Tepa (10 mg/ml) | | |
#### Summary of Clinical Testing
Not applicable.
#### CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K230121,Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
