Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Device Facts
| Record ID | K250342 |
|---|---|
| Device Name | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl |
| Applicant | Encompass Industries Sdn. Bhd. |
| Product Code | LZA · General Hospital |
| Decision Date | Jul 8, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.
Device Story
Disposable, non-sterile, powder-free polychloroprene examination glove; worn by healthcare personnel to prevent cross-contamination between patient and examiner. Device provides a physical barrier; tested for chemical permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978. Used in clinical settings; operator is the healthcare provider. Output is the physical barrier protection; clinical decision-making is supported by the glove's validated permeation breakthrough times, allowing providers to select appropriate protection for handling hazardous drugs. Benefits include reduced risk of dermal exposure to chemotherapy agents and fentanyl for the clinician.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including dimension, freedom from holes (ASTM D5151-19), physical properties (ASTM D412, D573), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, 10, 11). Chemotherapy drug permeation tested per ASTM D6978-05.
Technological Characteristics
Material: Polychloroprene. Form: Powder-free, non-sterile, green color. Dimensions: 240mm length, 0.05mm minimum thickness. Standards: ASTM D6977-19, ASTM D6978-05, 21 CFR 800.20. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity).
Indications for Use
Indicated for use as a disposable, non-sterile, powder-free patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Evaluated for permeation of specific chemotherapy drugs and fentanyl citrate per ASTM D6978. Warning: Do not use with Carmustine or ThioTepa.
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
- Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs (K212148)
Reference Devices
- Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (K220609)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 8, 2025
Encompass Industries Sdn. Bhd.
Atikah Muhyiddin
QA Manager
Lot 18256, Kawasan Perindustrian Lot Q,
Kertih Bio-Polymer Park
Kemaman, Terengganu 24300
Malaysia
Re: K250342
Trade/Device Name: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO, OPC
Dated: June 12, 2025
Received: June 12, 2025
Dear Atikah Muhyiddin:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250342 - Atikah Muhyiddin
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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 Quality System (QS) 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250342 - Atikah Muhyiddin
Page 3
assistance/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).
Sincerely,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control 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
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250342
Device Name
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.
The following chemotherapy drugs have been tested on the glove:
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time |
| --- | --- | --- |
| Carmustine* | 3.3 mg/mL | 23.2 min |
| Cisplatin | 1.0 mg/mL | >240 min |
| Cyclophosphamide | 20.0 mg/mL | >240 min |
| Dacarbazine | 10.0 mg/mL | >240 min |
| Doxorubicin HCL | 2.0 mg/mL | >240 min |
| Etoposide | 20.0 mg/mL | >240 min |
| Fluorouracil | 50.0 mg/mL | >240 min |
| Methotrexate | 25.0 mg/mL | >240 min |
| Paclitaxel | 6.0 mg/mL | >240 min |
| ThioTepa* | 10.0 mg/mL | 13.5 min |
| Mitomycin C | 0.5 mg/mL | >240 min |
| Vincristine Sulfate | 1.0 mg/mL | >240 min |
| Fentanyl | | |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 min |
*Please note that the following drugs have low permeation time.
1. Carmustine
2. ThioTepa
Warning: Do not use with Carmustine & ThioTepa
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
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FORM FDA 3881 (8/23)
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
K250342
510(k) Summary
Preparation Date: July 3, 2025
1. Submitter
Name : Encompass Industries Sdn. Bhd.
Address : Lot 18256, Kawasan Perindustrian Lot Q, Kertih Bio-Polymer Park, 24300 Kemaman, Terengganu, Malaysia.
Telephone No. : +609 831 8866
Contact Person : Atikah Muhyiddin
E-mail : regulatory@encompass-medical.com | atikah@ems-inc.com
2. Identification of Device
Trade/Proprietary Name(s) : Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Common Name(s) : Powder-Free Polychloroprene Examination Glove
Classification Name:
1. Non-powdered Patient Examination Glove (21 CFR 880.6250)
2. Polymer Patient Examination Glove (Product Code: LZA)
3. Patient Examination Glove, Specialty (Product Code: LZC)
4. Glove with Labelling Claims for Use with Chemotherapy Drugs (OPJ)
5. Fentanyl and Other Opioid Protective Glove (QDO)
6. Powder-Free Polychloroprene Patient Examination Glove (OPC)
Device Classification : Class I
3. Identification of Legally Marketed Device as Predicate and Reference Device
Predicate Device : Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
510(k) number : K212148
Company : Ansell Healthcare Products LLC
Reference Device : Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
510(k) number : K220609
Company : Encompass Industries Sdn. Bhd.
4. Description of Device
The proposed Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Polychloroprene. The gloves are not made with natural rubber latex. General specifications of the glove are as below:
1. Overall Length : 240 mm minimum
2. Width : 95 ± 5 mm minimum (for medium glove)
3. Palm Thickness : 0.05 mm minimum
4. Finger Thickness : 0.05 mm minimum
5. Cuff Thickness : 0.05 mm minimum
6. Tensile Strength
a. Before Aging : 14 MPa minimum
b. After Aging : 14 MPa minimum
7. Ultimate Elongation
a. Before Aging : 500 % minimum
b. After Aging : 400 % minimum
8. Pinhole AQL : 2.5
Page 1 of 8
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
# 5. Intended Use / Indication for Use:
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.
The following chemotherapy drugs have been tested on the glove:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (minutes) |
| --- | --- | --- |
| Carmustine (BCNU)* | 3.3 mg/ml | 23.2 min |
| Cisplatin | 1.0 mg/ml | >240 min |
| Cyclophosphamide | 20.0 mg/ml | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min |
| Etoposide | 20.0 mg/ml | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min |
| ThioTepa* | 10.0 mg/ml | 13.5 min |
| Mitomycin C | 0.5 mg/ml | >240 min |
| Vincristine Sulfate | 1.0 mg/ml | >240 min |
| *Warning Statement: | Please note that the following drugs have extremely low permeation time:
1. Carmustine (3.3 mg/ml)
2. ThioTepa (10.0 mg/ml) | |
| Fentanyl | Concentration | Minimum Breakthrough Detection Time (minutes) |
| --- | --- | --- |
| Fentanyl Citrate | 100 mcg/2mL | >240 min |
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
# 6. Comparative Technological Characteristics & Performance Information Summary
Table 6.1 Summary of Technological Characteristics Comparison between Proposed, Reference and Predicate Device
| Characteristic | Device Performance / Characteristic | | | Comparison Analysis | |
| --- | --- | --- | --- | --- | --- |
| | Predicate Device (K212148) | Reference Device (K220609) | Proposed Device (K250342) | Comparison | Any Safety & Effectiveness Issue |
| Glove Name | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Similar | No |
| Material | Polychloroprene | Nitrile | Polychloroprene | Similar to predicate | No |
| Color | Blue | White, Blue, Black, Orange, Green | Green | Minor Difference | No |
| Size | XS, S, M, L, XL | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | Similar | No |
| Device Classification Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Similar | No |
| Product Code | LZA, LZC | LZA, LZC | LZA, LZC, OPJ, QDO, OPC | Similar | No |
| Type of Use | Single Use | Single Use | Single Use | Similar | No |
| Rx / OTC | OTC | OTC | OTC | Similar | No |
| Powder-Free | Yes | Yes | Yes | Similar | No |
| Sterility | Non-sterile | Non-sterile | Non-Sterile | Similar | No |
| Intended Use / Indication for Use | A powder-free patient examination glove is a disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. | A disposable device intended for medical purposes that is worn on the examiner's hand, in order to prevent contamination between patient and examiner. This device is for over-the-counter use and is for single use only. In addition, these gloves were tested chemotherapy drug permeation test. | A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile. | Similar | No |
| Dimension | Meets requirement of ASTM D6977-19 | Meets requirement of ASTM D6319-19 | Meets requirement of ASTM D6977-19 | Similar | No |
| Physical Properties | Meets requirement of ASTM D6977-19 | Meets requirement of ASTM D6319-19 | Meets requirement of ASTM D6977-19 | Similar | No |
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
| Freedom from Holes | Meets requirement of ASTM D6977-19 | Meets requirement of ASTM D6319-19 and 21 CFR 800.20) | Meets requirement of ASTM D6977-19 and 21 CFR 800.20) | Similar¹ | No |
| --- | --- | --- | --- | --- | --- |
| Powder Residual | Meets requirement of ASTM D6977-19 | Meets requirement of ASTM D6319-19 | Meets requirement of ASTM D6977-19 | Similar | No |
| Biocompatibility | ISO 10993-10 Skin Irritation Under the conditions of the study, not an irritant | ISO 10993-10 Skin Irritation Not a primary skin irritant under the conditions of the study. | ISO 10993-10 Skin Irritation The test article was not considered as an irritant. | Similar | No |
| | ISO 10993-10 Skin Sensitization Under the conditions of the study, not a sensitizer | ISO 10993-10 Skin Sensitization Not a sensitizer under the conditions of the study. | ISO 10993-10 Skin Sensitization The test article was not considered a sensitizer. | Similar | No |
| | ISO 10993-5.In Vitro Cytotoxicity Under the conditions of the study undiluted, 1:2, and 1:4 dilutions were cytotoxic (grade 4). Dilutions of 1:8 (grade 2), 1:16 (grade 1), 1:32 and 1:64 (grade 0) were noncytotoxic. | ISO 10993-5.In Vitro Cytotoxicity Under the condition of study, the device extract shows potential toxicity. | ISO 10993-5.In Vitro Cytotoxicity The test extract showed evidence of toxicity. | Similar | No |
| | ISO 10993-11 Acute Systemic Toxicity Under the conditions of the study, no evidence of systemic toxicity | ISO 10993-11 Acute Systemic Toxicity Not an acute systemic toxic under the condition of the study. | ISO 10993-11 Acute Systemic Toxicity There was no evidence of acute systemic toxicity. | Similar | No |
¹Device performance demonstrates that the proposed device meets 21 CFR 800.20 as the tested samples show results below the rejection number at 2.5 AQL for patient examination glove, thus meet the requirement of ASTM D6977-19 which is Inspection G-1, AQL 2.5. Similar to predicate device.
Table 6.2 Summary of Difference in Technological Characteristics
| Characteristic | Predicate Device (K212148) | Reference Device (K220609) | Proposed Device (K250342) | Comparison Analysis | Justification |
| --- | --- | --- | --- | --- | --- |
| Color | Blue | White, Blue, Black, Orange, Green | Green | Different (Supported by Biocompatibility Study and Performance Testing) | Devices in different colors have the same non-sensitization, non-irritating and non-toxic characteristics and meet the same performance specifications. |
Page 4 of 8
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
Table 6.3: Test Results for Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (ASTM D6978-05) Comparison between Proposed, Reference and Predicate Device
| Chemotherapy Drugs & Concentration | Minimum Breakthrough Detection Time (minutes) | | | | | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Predicate Device (K212148) | Reference Device (K220609) | | | | | Proposed Device (K250342) | |
| | | White | Blue | Black | Orange | Green | | |
| Carmustine (3.3 mg/ml) | 45.4 | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 | 23.2 | Similar |
| Cisplatin (1.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Cyclophosphamide(20.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Dacarbazine (10.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Doxorubicin HCL (2.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Etoposide (20.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Fluorouracil (50.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Methotrexate (25.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Paclitaxel (6.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| ThioTepa (10.0 mg/mL) | 23.5 | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 | 13.5 | Similar |
| Mitomycin C (0.5 mg/mL) | - | >240 | >240 | >240 | >240 | >240 | >240 | Similar to K220609² |
| Vincristine Sulfate (1.0 mg/mL) | >240 | >240 | >240 | >240 | >240 | >240 | >240 | Similar |
| Fentanyl & Concentration | Minimum Breakthrough Detection Time (minutes) | | | | | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Predicate Device (K212148) | Reference Device (K220609) | | | | | Proposed Device (K250342) | |
| | | White | Blue | Black | Orange | Green | | |
| Fentanyl Citrate (100mcg/2mL) | - | >240 | >240 | >240 | >240 | >240 | >240 | Similar to K220609² |
²Chemotherapy and fentanyl drug names and its minimum breakthrough detection time of the proposed device will be listed on the packaging. Therefore, the differences do not raise concerns about safety, effectiveness and substantial equivalence of the proposed device compared to the predicate.
# 7. Summary of Non-Clinical Test:
Below are the non-clinical tests that were conducted and the purposes:
| Test | Purpose |
| --- | --- |
| Dimension Test | To evaluate whether the device meets the current ASTM D6977-19 |
| Freedom From Hole | To evaluate whether the subject meets current 21 CFR 800.20, ASTM D6977-19 and test according to ASTM D5151-19 |
| Physical Property Test | To evaluate whether the subjects meet current ASTM D6977-19 and test according to ASTM D412 and ASTM D573 |
| Residual Powder Test | To evaluate whether the subjects meet current ASTM D6977-19 and test according to ASTM D6124-06 |
| Biocompatibility Test (Skin Irritation) | To determine whether skin irritation potential of device meets ISO 10993-10. |
| Biocompatibility Test (Skin Sensitization) | To determine whether skin sensitization potential of device meets ISO 109993-10. |
| Biocompatibility Test (Acute Systemic Toxicity) | To determine whether leachable extracted from the device would cause acute systemic toxicity and meet ISO 10993-11. |
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Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
Table 7.1 Summary of Dimension Test
| Characteristics | Standard | Size | Requirement | Device Performance |
| --- | --- | --- | --- | --- |
| Length | ASTM D69779-19 | XS | ≥ 220 mm | ≥ 251 mm |
| | | S | ≥ 220 mm | ≥ 250 mm |
| | | M | ≥ 230 mm | ≥ 251 mm |
| | | L | ≥ 230 mm | ≥ 248 mm |
| | | XL | ≥ 230 mm | ≥ 250 mm |
| | | XXL | ≥ 230 mm | ≥ 250 mm |
| Width | | XS | 70 ± 10 mm | 79 - 80 mm |
| | | S | 80 ± 10 mm | 86 - 88 mm |
| | | M | 95 ± 10 mm | 98 - 100 mm |
| | | L | 110 ± 10 mm | 111 - 113 mm |
| | | XL | 120 ± 10 mm | 115 - 118 mm |
| | | XXL | 130 ± 10 mm | 127 - 129 mm |
| Thickness (Finger) | | XS | ≥ 0.05 mm | ≥ 0.11 mm |
| | | S | | ≥ 0.11 mm |
| | | M | | ≥ 0.11 mm |
| | | L | | ≥ 0.11 mm |
| | | XL | | ≥ 0.11 mm |
| | | XXL | | ≥ 0.11 mm |
| Thickness (Palm) | | XS | ≥ 0.05 mm | ≥ 0.08 mm |
| | | S | | ≥ 0.08 mm |
| | | M | | ≥ 0.08 mm |
| | | L | | ≥ 0.08 mm |
| | | XL | | ≥ 0.08 mm |
| | | XXL | | ≥ 0.09 mm |
| Thickness (Cuff) | | XS | ≥ 0.05 mm | ≥ 0.06 mm |
| | | S | | ≥ 0.07 mm |
| | | M | | ≥ 0.07 mm |
| | L | ≥ 0.07 mm | | |
| | XL | ≥ 0.07 mm | | |
| | XXL | ≥ 0.07 mm | | |
Table 7.2 Summary of Freedom of Hole Test
| Characteristics | Standard | Size | Requirement | Device Performance^{3} |
| --- | --- | --- | --- | --- |
| Freedom from Holes | ASTM D6977-19 21 CFR 800.20 (Tested according to ASTM D5151-19) | XS | AQL 2.5 | Passed |
| | | S | | Passed |
| | | M | | Passed |
| | | L | | Passed |
| | | XL | | Passed |
| | | XXL | | Passed |
$^{3}$ Device performance demonstrates that the proposed device meets 21 CFR 800.20 as the tested samples show results below the rejection number at 2.5 AQL for patient examination glove, thus meet the requirement of ASTM D6977-19 which is Inspection G-1, AQL 2.5. Similar to predicate device.
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{11}
Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
Table 7.3 Summary of Physical Property Test
| Characteristics | Standard | Size | Minimum Requirement | Device Performance |
| --- | --- | --- | --- | --- |
| Before Aging (Tensile [MPa]) | ASTM D6977-19
(Tested as per ASTM D412-16 and ASTM D573) | XS | 14 MPa | 23.9 |
| | | S | | 21.7 |
| | | M | | 33.4 |
| | | L | | 28.9 |
| | | XL | | 27.5 |
| | | XXL | | 16.83 |
| Before Aging (Elongation [%]) | | XS | 500 % | 521 |
| | | S | | 551 |
| | | M | | 596 |
| | | L | | 554 |
| | | XL | | 591 |
| | | XXL | | 556 |
| After Aging (Tensile [MPa]) | | XS | 14 MPa | 30.4 |
| | | S | | 33.0 |
| | | M | | 40.2 |
| | | L | | 23.8 |
| | | XL | | 26.2 |
| | | XXL | | 29.9 |
| After Aging (Elongation [%]) | | XS | 400 % | 448 |
| | | S | | 428 |
| | | M | | 462 |
| | L | 438 | | |
| | XL | 453 | | |
| | XXL | 461 | | |
Table 7.4 Summary of Residual Powder Test
| Characteristics | Standard | Size | Requirement | Device Performance^{4} |
| --- | --- | --- | --- | --- |
| Residual Powder (mg) | ASTM D6977-19 | XS | ≤ 2.0 mg of residual powder per glove | 0.30 mg/glove |
| | | S | | 0.32 mg/glove |
| | | M | | 0.24 mg/glove |
| | ASTM D6124-06 | L | | 0.26 mg/glove |
| | | XL | | 0.22 mg/glove |
| | | XXL | | 0.30 mg/glove |
*Device Performance shows the residual powder content of each glove size, which meets ASTM D6977-19 and ASTM D6124-06 (2017) requirements for Powder Free Gloves; ≤ 2 mg per glove. Similar to predicate device.
Table 7.5 Summary of Biocompatibility Test
| Characteristics | Standard | Requirement | Device Performance |
| --- | --- | --- | --- |
| Skin Irritation | ISO 10993-10 | Score ≤ 0.4 | The test article was not considered as an irritant. |
| Skin Sensitization | ISO 10993-10 | Score < 1 | The test article was not considered a sensitizer. |
| Acute Systemic Toxicity | ISO 10993-11 | No significant biological reactivity | There was no evidence of acute systemic toxicity. |
Page 7 of 8
{12}
Encompass Industries Sdn. Bhd.
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Premarket Notification Submission - Traditional 510(k)
## 8. Summary of Clinical Test:
Clinical data is not required.
## 9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices.
Page 8 of 8
