A patient examination glove is a disposable device intended for medical purposes that 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 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, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.

AI/ML Overview

This 510(k) summary is for a medical device (Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves) and does not describe AI/ML software. Therefore, many of the requested fields are not applicable.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Physical and Dimensions Testing:	Meets requirements for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0) per ASTM D5250-00.
Pinhole Requirements (Water Fill Test):	Meets requirements with samplings of AQL 2.5, Inspection Level I, per FDA 1000 ml. Water Fill Test.
Biocompatibility (Skin Irritation):	No primary skin irritant or sensitization reactions observed in Primary Skin Irritation and Skin Sensitization testing.
Biocompatibility (Sensitization):	No primary skin irritant or sensitization reactions observed in Primary Skin Irritation and Skin Sensitization testing.
ASTM Standard Compliance:	Conforms fully to ASTM-D-5250-00 standard.
CFR References:	Conforms fully to applicable 21 CFR references.

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

Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but these are standard sampling plans).
Water Fill Test: Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but these are standard sampling plans).
Biocompatibility Testing: Not specified whether samples were prospective or retrospective. No explicit country of origin provided for the test data, but the manufacturer is in China.

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)

Not applicable. This device is a physical product (gloves), and ground truth is established through standardized physical, chemical, and biological tests rather than expert interpretation of medical images or data.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for objective standardized testing of physical product properties.

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

Not applicable. This device is a patient examination glove and does not involve AI or human reader assistance.

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

Not applicable. This device is a patient examination glove and does not involve an algorithm.

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

The ground truth for the device's performance was established through:

Adherence to ASTM Standard D5250-00 (for physical and dimensional properties).
Compliance with FDA 1000 ml. Water Fill Test requirements (for pinhole detection).
Results from Primary Skin Irritation and Skin Sensitization testing (for biocompatibility).

These are objective, standardized laboratory and biological test results.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, and therefore no training set or associated ground truth establishment method for a training set is relevant.

Summary

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JUL 1 7 2001

510(K) SUMMARY

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan, Hebei Province P.R. China

Date Summary Prepared: May 11, 2001

2. Name of the Device:

Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd.

Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves K#992862

Device Description: 4.

5. Intended Use:

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6. Comparison to Predicate Devices:

Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves, is substantially equivalent in safety and v firy Futuring Litaniang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Eversharp Plastics Products Co., Ltd. glove Frie standards about on ASTM-D-5250-00. 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 I, meeting these requirements. Primary Skin irritation and Skin mispection 2019, in the 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.

Discussion of Clinical Tests Performed: 8.

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Eversharp Plastics Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination gloves conform fully to ASTM-D-5250-00 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2001

Shijiazhuang Eversharp Plastic Products Co., Ltd. C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 12390 East End Avenue Chino, California 91710

K011883 Re : Powdered Synthetic (Yellow) Vinyl Trade/Device Name: Patient Examination Gloves 880.6250 Regulation Number: Regulatory Class: I Product Code: LYZ Dated: May 18, 2001 Received: June 18, 2001

Dear Mr. Chu:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceren. beve and we have determined the market the device ferenced above (for the indications for device is substancially organismination to Merceded predicate use stated in the encrobare, or Ing 2002 - 1976, devices marketed in theerbead of the Medical Device Amendments, or to the enactment uate of the hearonial in accordance with the devices that have been recrably Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reacrar rood, broy, subject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act incraac request manufacturing practice, registration, freeing or a a a misbranding and adulteration.

If your device is classified (see above) into either class II II your device is crabbirsa (so(remarket Approval), it may (Special Concrols) of Stiphal controls. Existing major be subject to such address.ar be found in the Code of regulations arrecting foll 21, Parts 800 to 895. ਸੋ Federal Regulations, freic ar, basemes compliance with substancially equivalEacturing Practice requirements, as set the Current Sood hands as the System Regulation (QS) for Medical Lorch In the Quarrey ByBoom Kogard Rogart 820) and that, Devices: General regarations, the Food and Drug through periodic QS inspections, ench assumptions. Failure to
Administration (FDA) will verify such in romany in romal tory Administracton (FBA) will result in regulation may result in regulatory

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Page 2 - Mr. Chu

In addition, FDA may publish further announcements Please note: action. action. In addition, First May paderal Register.
concerning your device in the Federal Register. concerning your device in the reductions.
this response to your premarket notification submission does this response to your premarket noctrreactor same not affect any obligation you might made the Electronic
through 542 of the Act for devices under the Electronic through 542 of the Act for devices under the Becorement of the regulations.

This letter will allow you to begin marketing your device as the FDA This letter will allow you to begin mainteeung your man fDA
described in your 510(k) premarket notification. The f described in your 510(k) premarker not receive to a legally
finding of substantial equivalence of your device to a legally finding of substantial equivalence of your actises on for your marketed predicate device results in a crabblession and the market.

If you desire specific advice for your device on our labeling a
nd for and a FFP Bost 801 additionally 809.10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Part 801 and additionaly, for guestic vitro diagnostic devices), please conculture on one on on Compliance at (301) 594-4622. Address, as a sease contact
the promotion and advertising of your device, please not the promotion and advertising of (301) 594-4639. Also, please note
the Office of Compliance at (301) 594-4639. Also, professor (3 the Office of Compriands wisbranding by reference to Other general the regarde-staffication" (21CFR 807.97). premarket notification" (21CHK 807.97). October 2017
information on your responsibilities under the Act may be information on your responsibilities under the 110 mm]
obtained from the Division of Small Manufacturers Assistance
11 for all for mumber (800) 638-2041 or (301) 443-6597 or obtained from the Division of Smarr Manufaceared on 2011
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timothy Director 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

KO11883 (IF KNOWN) : 510(K) NUMBER Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves

A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Qlin S. hin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 513;k) Number .

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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

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.