A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Performance Requirement	Reported Device Performance
ASTM D-5250-92 (Physical and Dimensions Testing)	All requirements stated in ASTM D-5250-92	Meets all requirements
FDA 1000 ml. Water Fill Test	AQL 2.5, Inspection Level S-4	Meets requirements
Primary Skin Irritation	No primary skin irritant reactions	No primary skin irritant reactions
Skin Sensitization (Allergic Contact Dermatitis)	No sensitization reactions	No sensitization reactions
Pinholes	Meets FDA requirements	Meets FDA requirements
Biocompatibility	N/A (implied by skin irritation/sensitization tests)	Meets requirements
Labeling Claims	N/A (no special claims, not hypoallergenic)	Conforms to claims
GMP Compliance	Compliance with FDA's GMPs	Operates in compliance

Study Details

Sample sizes used for the test set and the data provenance:
- Test Sets for Physical and Dimensions, Water Fill Test:
  - Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size n would depend on the batch size, as per ASTM sampling tables for Inspection Level S-2.
  - FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size n would depend on the batch size, as per FDA or ASTM sampling tables for Inspection Level S-4.
- Test Sets for Primary Skin Irritation and Skin Sensitization: Not specified, but "samplings" were used.
- Data Provenance: Not explicitly stated, but the company is based in Shanghai, China, suggesting the testing was performed on products manufactured there. It is a retrospective summary of tests performed to demonstrate compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is based on objective measurements against established standards (ASTM D-5250-92, FDA water fill test criteria) and biological testing protocols for skin irritation/sensitization, not expert consensus on interpretations of images or findings.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests involve direct measurement against defined physical or biological criteria.
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: Not applicable. This device is a pre-powdered vinyl examination glove, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical and Dimensions: Objective measurements compared against the specifications defined in ASTM D-5250-92.
- Water Fill Test (Pinhole): Objective observation of water leakage, compared against the acceptance criteria (AQL 2.5).
- Primary Skin Irritation and Skin Sensitization: Biological responses (e.g., skin reactions) observed in tested subjects (likely animals or human volunteers for patch tests), against predefined criteria for irritant or sensitizing reactions.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI device.

Summary

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SHANGHAI GLOVMAX ENTERPRISE CO., LTD.

Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.

JAN 1 2 2000

TEL: 886-2-25462479 FAX: 886-2-25147612

K 993859

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

1.Submitter's Identification:

Mr. Mao-Sheng Lee SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China

Date Summary Prepared: Nov. 5, 1999

2. Name of the Device:

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Pre-powdered Vinyl Examination Gloves

3. Predicate Device Information:

Shanghai Huamao Gloves Co., Ltd. #K984461

4. Device Description:

5.Intended Use:

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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SHANGHAI GLOVMAX ENTERPRISE CO., LTD.

Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.

TEL: 886-2-25462479 FAX: 886-2-25147612

6. Comparison to Predicate devices:

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Pre-powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Huamao Gloves Co., Ltd. Pre-powdered vinyl patient examination Gloves.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Production are based on ASTM D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Operates in compliance with FDA's GMPs.

8. Discussion of Clinical Tests Performed:

Not Applicable - There is not hypoallergenic claim.

9.Conclusions:

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Vinyl Patient Examination Gloves conform fully to ASTM D-5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the " substantial equivalence" products cited.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. Mao-Sheng Lee, President Shanghai Glovmax Enterprise Co., Ltd. Room B, 11th Floor, No. 201 Nanking E. Road, Sec. 3 Taipei, Taiwan, R.O.C.

Re: K993859 Shanghai Glovmax Enterprise Co., Ltd. Pre-Trade Name: Powdered Vinyl Patient Examination Gloves Regulatory Class: I Product Code: LYZ November 5, 1999 Dated: November 15, 1999 Received:

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Lee

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT A

Page _ 1__ of _ 1 _

510(k) number (if known): K993859

Shanghai Glovmax Enterprise Co., Ltd. Device name: Pre-powdered Vinyl Examination Gloves

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Clive S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number

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.