Disposable Vinyl Examination Gloves 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.

Device Description

The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

CHARACTERISTICS	STANDARDS	Acceptance Criteria	DEVICE PERFORMANCE (Reported)
Dimensions	ASTM D5250-19		Pass
Length		230 mm min	240 mm min
Width (S)		$85\pm5$ mm	89-90 mm
Width (M)		$95\pm5$ mm	99 mm
Width (L)		$105\pm5$ mm	105-106 mm
Width (XL)		$115\pm5$ mm	119-120 mm
Thickness (Palm)		Min 0.08 mm	0.080 mm Min
Thickness (Finger)		Min 0.08 mm	0.080 mm Min
Physical Properties	ASTM D5250-19		Pass
Before Aging:
Tensile Strength		11 MPa, min.	16.0 MPa, min.
Elongation		300%, min.	304%, min.
After Aging:
Tensile Strength		11 MPa, min.	16.7 MPa, min.
Elongation		300%, min.	301%, min.
Freedom from holes	ASTM D5250-19,	No leakage at sampling level of	Pass
	ASTM D5151-19	G-1, AQL 2.5	No leakage, 80 of 80 passed
Residual Powder	ASTM D6124-06	<2 mg per glove	0.1 mg per glove (average)
Biocompatibility	ISO 10993-23:2021	Not an irritant	Did not induce skin irritation
(Primary Skin Irritation)
Biocompatibility	ISO 10993-10:2010	Not a sensitizer	Did not cause skin sensitization reaction
(Dermal Sensitization)
Biocompatibility	ISO 10993-5:2009	No potential toxicity to L-929_cells	Did not show potential toxicity to L-929 cells_
(In vitro Cytotoxicity)

Additional Information (As applicable to this type of device)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Physical Performance Testing: For "Freedom from holes," the reported sample size was "80 of 80 passed." Other physical tests (dimensions, physical properties, residual powder) often rely on samples drawn from manufacturing lots according to the specified ASTM standards, but specific sample sizes for each characteristic are not explicitly stated beyond what's implied by the standards.
Biocompatibility Testing: The standards (ISO 10993 series) define the protocols and sample sizes for these tests, but specific numbers are not provided in this summary.
Data Provenance: Not explicitly stated, but assumed to be from Anqing Pukang Medical Technology Co., LTD. in China, where the device is manufactured. The tests are prospective, as they are part of the premarket notification process for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory protocols, not by expert interpretation in a clinical context. The results are quantitative measurements or observations of biological reactions performed by qualified lab personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. This concept is primarily relevant to studies involving human subjective evaluation or complex diagnostic interpretation where disputes need resolution. Performance testing for gloves involves objective measurements or standardized biological assays.

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

N/A. This is a physical device, not an AI/software device. No human reader studies are relevant.

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

N/A. This is a physical device, not an AI/software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For physical properties and dimensions: Standards-based objective measurements.
For freedom from holes: Pass/fail criteria based on water leak test per ASTM standards.
For residual powder: Quantitative measurement per ASTM standards.
For biocompatibility: Laboratory assays and observations of biological reactions (e.g., skin irritation, sensitization, cytotoxicity) as defined by ISO 10993 series standards.

8. The sample size for the training set

N/A. This is a physical device, not an AI/software device. No training set is used.

9. How the ground truth for the training set was established

N/A. This is a physical device, not an AI/software device. No training set or associated ground truth is relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2024

Anqing Pukang Medical Technology Co., LTD. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K241252

Trade/Device Name: Disposable Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: May 3, 2024 Received: May 3, 2024

Dear Prithul Bom:

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 Quality 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 mediation-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,

Allan Guan -S

For 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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Indications for Use

510(k) Number (if known) K241252

Device Name Disposable Vinyl Examination Gloves

Indications for Use (Describe)

Disposable Vinyl Examination Gloves 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. Date prepared: May 20, 2024 A. Applicant:

Name: Anqing Pukang Medical Technology Co., LTD. Address: No 7 Haian Road, Anqing City, Anhui,China. Contact: Ms. Min Gao Title: QE Tel: +86-18266365220 Email: 474112523@qq.com

Submission Correspondent: Primary contact: Max Li Anqing Pukang Medical Technology Co., LTD. No 7 Haian Road, Anqing City, Anhui,China. Tel: +86-536-6136888 Email: maxli@basicmedical.com

B. Device:

Trade Name: Disposable Vinyl Examination Gloves Common Name: Non-Powdered Patient Examination Glove

Regulatory Information Classification Name: Vinyl Patient Examination Glove Classification: Class I Product code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital and Personal Use

C. Predicate device:

K223008 Name of the device: Disposable Vinyl Examination Gloves Owner's Name: JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD.

D. Indications for use of the device:

Disposable Vinyl Examination Gloves is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

Device Description: نن

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specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

F. Summary of Technological Characteristics

Disposable Vinyl Examination Gloves are compared with the predicate device in terms of intended use, design, material, specifications, and performance.

The following table shows similarities and differences of use, design, and material between the proposed device and the predicate device.

Device	Proposed Device	Predicate Device	Result
510K #	K241252	K223008	-
Product Name	Disposable Vinyl Examination Gloves	Disposable Vinyl Examination Gloves	-
Product Code	LYZ	LYZ	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Indications for use	Disposable Vinyl Examination Gloves 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.	Disposable Vinyl Examination Gloves 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.	Same
Powder free	Yes	Yes	Same
Design feature	Ambidextrous.	Ambidextrous.	Same
Material	Vinyl	Vinyl	Same
Color	Clear	Clear	Same
Size	S, M, L, XL	S, M, L, XL	Same
Sterile	Non-Sterile	Non-Sterile	Same
Use	Singe use	Single use	Same

Table 1 General Comparison of Proposed and Predicate Devices

Table 2 Comparison of Physical, Biocompatibility and Performance Testing

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		Remarks
		SUBJECT	PREDICATE
Name of device		Disposable VinylExamination Gloves	Disposable VinylExamination Gloves	---
Dimensions	ASTMD5250- 19	Length:S/M/L/XL: ≥230;	Length:S/M/L/XL: ≥230;	Same

Physical Properties	ASTMD5250- 19	Width:	Width:	Same
		S: 85±5M: 95±5L: 105±5XL: 115±5	S: 85±5M: 95±5L: 105±5XL: 115±5
		Thickness:Palm: ≥0.08Finger: ≥0.08	Thickness:Palm: ≥0.08Finger: ≥0.08
		Before AgingTensile Strengthmin 11 MpaUltimate ElongationMin 300%	Before AgingTensile Strengthmin 11 MpaUltimate ElongationMin 300%
		After AgingTensile Strengthmin 11 MpaUltimate ElongationMin 300%	After AgingTensile Strengthmin 11 MpaUltimate ElongationMin 300%
Powder Free	ASTMD5250- 19	≤2 mg/glove	≤2 mg/glove	Same
Freedom from Holes	ASTM D5250- 19ASTM D5151- 19	Complies withASTM D5250- 19and ASTM D5151- 19 G-1, AQL 2.5	Complies withASTM D5250- 19and ASTM D5151- 19 G-1, AQL 2.5	Same
Biocompatibility	Primary SkinIrritation-ISO 10993-23:2021;	Under the conditions of thisstudy, the polar andnonpolar extracts of the testarticle did not induce skinirritation.	Under the conditions ofthe study, not an irritant	Similar①
	DermalSensitization-ISO 10993-10:2010	Under the conditions ofthis test, the polar andnon-polar extracts of thetest article did not causeskin sensitizationreaction.	Under the conditions ofthe study, not a sensitizer	Same
	In vitrocytotoxicityISO10993-5:2009	Under the conditions ofthis study, the extract ofthe test article did notshow potential toxicity toL-929 cells.	Under conditions of thestudy, did not showpotential toxicity to L-929 cells. Complies with	Same

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(1) The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10

Analysis: The proposed device has the Skin Sensitization test, Primary Skin Irritation test and the In vitro cytotoxicity test, the same as the predicate device.

G. Summary of Non-Clinical Testing

A Biocompatibility

Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluated the biocompatibility of Disposable Vinyl Examination Gloves:

ISO 10993-10: Skin Sensitization test
ISO 10993-23:Skin Irritation test
· ISO 10993-5: In vitro cytotoxicity test

A Performance Testing

Physical performance testing of the proposed device was conducted as per ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Examination Gloves.

To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

Test Method	Purpose	Acceptance Criteria	Results
Dimensions(length)(width)(thickness)	The purpose of thetest is to evaluate thephysical dimension ofthe glove	Length230 mm min	Pass240 mm min
		Width(mm)	Pass
		S: $85\pm5$M: $95\pm5$L: $105\pm5$XL: $115\pm5$	S: 89-90mmM: 99 mmL:105-106 mmXL:119-120 mm
		Thickness(mm):Palm: Min 0.08Finger: Min 0.08	PassPalm – 0.080mm MinFinger–0.080mm Min
Physicalproperties	The purpose of thetest is to evaluate thetensile strength andultimate elongationbefore and afteraging	Before Aging:Tensile Strength: 11 MPa, min.Elongation: 300%, min.	PassBefore Aging:Tensile Strength: 16.0MPa, min.Elongation: 304%, min.
		After Aging:Tensile Strength: 11 MPa, min.Elongation:300%, min.	After Aging:Tensile Strength:16.7MPa, min.Elongation: 301%, min.

Freedom fromholes	The purpose of thetest is to detect holesin the gloves	No leakage at sampling level ofG-1, AQL 2.5	PassNo leakage, 80 of 80 passed

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ResidualPowder	The purpose of thetest is to detect thepowder residue inthe glove	<2mg per glove	Passaverage 0.1 mg per glove
--------------------	-------------------------------------------------------------------------------	----------------	----------------------------------

H. Clinical Test Conclusion

No clinical study is included in this submission.

l. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Disposable Vinyl Examination Gloves, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K223008.

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.