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	Concentration	Breakthrough Detection Time
Fentanyl Citrate	100.0 mcg/2mL	>240 min

*Please note that the following drugs have low permeation time.

Carmustine
ThioTepa

Warning: Do not use with Carmustine & ThioTepa

Device Description

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:

Overall Length: 240 mm minimum
Width: 95 ± 5 mm minimum (for medium glove)
Palm Thickness: 0.05 mm minimum
Finger Thickness: 0.05 mm minimum
Cuff Thickness: 0.05 mm minimum
Tensile Strength
- a. Before Aging: 14 MPa minimum
- b. After Aging: 14 MPa minimum
Ultimate Elongation
- a. Before Aging: 500 % minimum
- b. After Aging: 400 % minimum
Pinhole AQL: 2.5

AI/ML Overview

The provided FDA 510(k) clearance letter and associated documentation pertain to a Powder-Free Polychloroprene Examination Glove. This is a physical medical device, not an AI/software device. Therefore, the questions related to AI/software performance criteria (such as multi-reader multi-case studies, human-in-the-loop performance, training/test set ground truth, and expert adjudication) are not applicable to this documentation.

The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the gloves, and their resistance to permeation by chemotherapy drugs and fentanyl.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, focusing on the relevant physical device aspects:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

Characteristic	Standard / Requirement	Device Performance (Proposed Device K250342)
Dimensions	ASTM D6977-19
Length (XS)	≥ 220 mm	≥ 251 mm
Length (S)	≥ 220 mm	≥ 250 mm
Length (M)	≥ 230 mm	≥ 251 mm
Length (L)	≥ 230 mm	≥ 248 mm
Length (XL)	≥ 230 mm	≥ 250 mm
Length (XXL)	≥ 230 mm	≥ 250 mm
Width (XS)	70 ± 10 mm	79 - 80 mm
Width (S)	80 ± 10 mm	86 - 88 mm
Width (M)	95 ± 10 mm	98 - 100 mm
Width (L)	110 ± 10 mm	111 - 113 mm
Width (XL)	120 ± 10 mm	115 - 118 mm
Width (XXL)	130 ± 10 mm	127 - 129 mm
Thickness (Finger)	≥ 0.05 mm	≥ 0.11 mm
Thickness (Palm)	≥ 0.05 mm	≥ 0.08 mm
Thickness (Cuff)	≥ 0.05 mm	≥ 0.06 mm
Freedom from Holes	ASTM D6977-19, 21 CFR 800.20 (AQL 2.5)	Passed (for all sizes XS-XXL)
Physical Properties	ASTM D6977-19 (ASTM D412-16, D573)
Before Aging (Tensile)	≥ 14 MPa	16.83 - 33.4 MPa (depending on size)
Before Aging (Elongation)	≥ 500 %	521 - 596 % (depending on size)
After Aging (Tensile)	≥ 14 MPa	23.8 - 40.2 MPa (depending on size)
After Aging (Elongation)	≥ 400 %	428 - 462 % (depending on size)
Residual Powder	ASTM D6977-19, ASTM D6124-06 (≤ 2.0 mg/glove)	0.22 - 0.32 mg/glove (depending on size)
Biocompatibility
Skin Irritation	ISO 10993-10 (Score ≤ 0.4)	Not considered an irritant
Skin Sensitization	ISO 10993-10 (Score < 1)	Not considered a sensitizer
Acute Systemic Toxicity	ISO 10993-11 (No significant biological reactivity)	No evidence of acute systemic toxicity
Chemotherapy Drug Permeation	ASTM D6978-05 (Minimum Breakthrough Detection Time)
Carmustine	-	23.2 min*
Cisplatin	-	>240 min
Cyclophosphamide	-	>240 min
Dacarbazine	-	>240 min
Doxorubicin HCL	-	>240 min
Etoposide	-	>240 min
Fluorouracil	-	>240 min
Methotrexate	-	>240 min
Paclitaxel	-	>240 min
ThioTepa	-	13.5 min*
Mitomycin C	-	>240 min
Vincristine Sulfate	-	>240 min
Fentanyl Permeation	ASTM D6978-05 (Minimum Breakthrough Detection Time)
Fentanyl Citrate	-	>240 min

*Note: The document explicitly warns that Carmustine and ThioTepa have low permeation times and should not be used with the glove. This is a crucial labeling instruction based on the test results.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each physical, chemical, and permeation test. However, tests are typically performed on a statistically relevant number of samples to ensure representativeness and robust results according to the specified ASTM and ISO standards.
Data Provenance: The tests appear to have been conducted by Encompass Industries Sdn. Bhd. or a contracted lab on their behalf. The company is located in Kertih Bio-Polymer Park, Kemaman, Terengganu, Malaysia. The data is prospective in the sense that the tests were specifically performed on the proposed device for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable as the document describes a physical medical device (examination glove) and its material/permeation performance, not a software/AI device that requires expert human interpretation of data for ground truth establishment. The "ground truth" for these tests is based on objective, standardized laboratory measurements (e.g., precise measurements of length, thickness, tensile strength; chemical analysis for powder residue; standardized biological assays for biocompatibility; and analytical chemistry for drug permeation breakthrough times).

4. Adjudication Method for the Test Set

This question is not applicable for the same reason as point 3. Testing of physical device characteristics and chemical permeation is typically performed according to established laboratory protocols with quantitative, measurable endpoints, not through a process of expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the document describes a physical medical device (examination glove), not an AI-assisted diagnostic or therapeutic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the document describes a physical medical device (examination glove), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the examination gloves is based on objective, standardized laboratory measurements and adherence to established international and national standards (e.g., ASTM D6977-19, ASTM D6319-19, ASTM D5151-19, ASTM D412-16, ASTM D573, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11, 21 CFR 800.20).
- Examples include:
  - Physical measurements: Direct measurement of glove dimensions (length, width, thickness).
  - Mechanical properties: Tensile strength and elongation determined by standard material testing methods.
  - Integrity: Freedom from holes determined by water leak testing (ASTM D5151-19).
  - Chemical analysis: Measurement of residual powder.
  - Biocompatibility: In-vivo (skin irritation, sensitization, acute systemic toxicity) tests using animal models, following ISO standards.
  - Permeation: Breakthrough detection time of specific chemotherapy drugs and fentanyl using analytical methods (ASTM D6978-05).

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, which does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

FDA 510(k) Clearance Letter - K250342

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

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.

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K250342 - Atikah Muhyiddin Page 2

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-

Page 3

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

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	Concentration	Breakthrough Detection Time
Fentanyl Citrate	100.0 mcg/2mL	>240 min

*Please note that the following drugs have low permeation time.

Carmustine
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) Page 1 of 2

Page 5

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 2 of 2

Page 6

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)
Page 1 of 8

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:

Non-powdered Patient Examination Glove (21 CFR 880.6250)
Polymer Patient Examination Glove (Product Code: LZA)
Patient Examination Glove, Specialty (Product Code: LZC)
Glove with Labelling Claims for Use with Chemotherapy Drugs (OPJ)
Fentanyl and Other Opioid Protective Glove (QDO)
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

Overall Length: 240 mm minimum
Width: 95 ± 5 mm minimum (for medium glove)
Palm Thickness: 0.05 mm minimum
Finger Thickness: 0.05 mm minimum
Cuff Thickness: 0.05 mm minimum
Tensile Strength
- a. Before Aging: 14 MPa minimum
- b. After Aging: 14 MPa minimum
Ultimate Elongation
- a. Before Aging: 500 % minimum
- b. After Aging: 400 % minimum
Pinhole AQL: 2.5

Page 7

K250342

510(k) Summary

Preparation Date: July 3, 2025

1. Submitter

2. Identification of Device

Non-powdered Patient Examination Glove (21 CFR 880.6250)
Polymer Patient Examination Glove (Product Code: LZA)
Patient Examination Glove, Specialty (Product Code: LZC)
Glove with Labelling Claims for Use with Chemotherapy Drugs (OPJ)
Fentanyl and Other Opioid Protective Glove (QDO)
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

4. Description of Device

Overall Length: 240 mm minimum
Width: 95 ± 5 mm minimum (for medium glove)
Palm Thickness: 0.05 mm minimum
Finger Thickness: 0.05 mm minimum
Cuff Thickness: 0.05 mm minimum
Tensile Strength
- a. Before Aging: 14 MPa minimum
- b. After Aging: 14 MPa minimum
Ultimate Elongation
- a. Before Aging: 500 % minimum
- b. After Aging: 400 % minimum
Pinhole AQL: 2.5

Page 1 of 8

Page 8

5. Intended Use / Indication for Use:

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:

Carmustine (3.3 mg/ml)
ThioTepa (10.0 mg/ml)

Fentanyl	Concentration	Minimum Breakthrough Detection Time (minutes)
Fentanyl Citrate	100 mcg/2mL	>240 min

Page 9

5. Intended Use / Indication for Use:

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:

Carmustine (3.3 mg/ml)
ThioTepa (10.0 mg/ml)

Fentanyl	Concentration	Minimum Breakthrough Detection Time (minutes)
Fentanyl Citrate	100 mcg/2mL	>240 min

Page 2 of 8

Page 10

6. Comparative Technological Characteristics & Performance Information Summary

Table 6.1 Summary of Technological Characteristics Comparison between Proposed, Reference and Predicate Device

Characteristic	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

Page 11

6. Comparative Technological Characteristics & Performance Information Summary

Table 6.1 Summary of Technological Characteristics Comparison between Proposed, Reference and Predicate Device

Characteristic	Predicate Device (K212148)	Reference Device (K220609)	Proposed Device (K250342)	Comparison Analysis	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

Page 3 of 8

Page 12

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.

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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.

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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
Cisplatin (1.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Cyclophosphamide(20.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Dacarbazine (10.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Doxorubicin HCL (2.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Etoposide (20.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Fluorouracil (50.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Methotrexate (25.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Paclitaxel (6.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
ThioTepa (10.0 mg/mL)	23.5	25.2	21.5	11.1	47.8	169.1	13.5
Mitomycin C (0.5 mg/mL)	-	>240	>240	>240	>240	>240	>240
Vincristine Sulfate (1.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240

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

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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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
Cisplatin (1.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Cyclophosphamide (20.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Dacarbazine (10.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Doxorubicin HCL (2.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Etoposide (20.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Fluorouracil (50.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Methotrexate (25.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
Paclitaxel (6.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240
ThioTepa (10.0 mg/mL)	23.5	25.2	21.5	11.1	47.8	169.1	13.5
Mitomycin C (0.5 mg/mL)	-	>240	>240	>240	>240	>240	>240
Vincristine Sulfate (1.0 mg/mL)	>240	>240	>240	>240	>240	>240	>240

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

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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Table 7.1 Summary of Dimension Test

Characteristics	Standard	Size	Requirement	Device Performance
Length	ASTM D6977-19	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 Performance³
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

³Device 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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Table 7.1 Summary of Dimension Test

Characteristics	Standard	Size	Requirement	Device Performance
Length	ASTM D6977-19	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 Performance³
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

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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 Performance⁴
Residual Powder (mg)	ASTM D6977-19 ASTM D6124-06	XS	≤ 2.0 mg of residual powder per glove	0.30 mg/glove
		S		0.32 mg/glove
		M		0.24 mg/glove
		L		0.26 mg/glove
		XL		0.22 mg/glove
		XXL		0.30 mg/glove

⁴Device 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.

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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.

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Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.