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, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.

AI/ML Overview

The provided text describes the acceptance criteria and performance of Vinyl Patient Examination Gloves, Powdered, submitted by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. This submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial for novel device performance. Therefore, many of the typical elements of a study proving performance against acceptance criteria (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or not provided in the same manner as for a new, complex medical device.

However, based on the provided text, here's an analysis of the acceptance criteria and the "study" (non-clinical performance data) that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (from ASTM D5250-92)	Reported Device Performance (Applicant Device)
Length (mm)
Size S	Min. 230 mm	240 ± 5 mm
Size M	Min. 230 mm	240 ± 5 mm
Size L	Min. 230 mm	240 ± 5 mm
Size XL	Min. 230 mm	240 ± 5 mm
Width (mm)
Size S	85 ± 5 mm	87 ± 3 mm
Size M	95 ± 5 mm	98 ± 3 mm
Size L	105 ± 5 mm	106 ± 3 mm
Size XL	115 ± 5 mm	114 ± 3 mm
Thickness (mm)
Finger	Min. 0.05 mm	Min. 0.08 mm
Palm	Min. 0.08 mm	Min. 0.11 mm
Physical Properties Before Aging
Tensile Strength (MPa)	Min. 9 MPa	Min. 10 MPa
Ultimate Elongation (%)	Min. 300%	Min. 300%
Physical Properties After Aging
Tensile Strength (MPa)	Min. 9 MPa	Min. 9.5 MPa
Ultimate Elongation (%)	Min. 300%	Min. 300%
FDA Water Leak Test	(Implicitly, to meet AQL 4.0)	Meets AQL 4.0 with an Inspection Level of S-4
Biocompatibility (Modified Draize Test)	Absence of clinically significant irritation or allergic contact dermatitis	Did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of gloves) used for each physical and water leak test. The data provenance is implied to be from the manufacturer (Shanghai Foremost Plastic Industrial Co., Ltd.) and tested according to ASTM and FDA standards. It's an internal validation by the manufacturer. The data is most likely prospective testing conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable in the context of this device. The "ground truth" for the physical and water leak tests is established by the specified ASTM D5250-92 standard and the FDA 1000 ml water leak test protocol. These are objective measurements against defined criteria, not subjective interpretations requiring expert consensus like in image analysis or clinical diagnosis.
For the Modified Draize Test, presumably, medical professionals or dermatologists would have evaluated the human subjects, but the number and specific qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against a standard, not subjective assessments requiring 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

Not applicable. This device is a physical product (gloves) and does not involve AI or human readers/interpreters in its intended use.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

Physical Properties (Length, Width, Thickness, Tensile Strength, Elongation): The "ground truth" is established by the ASTM D5250-92 standard, which defines the acceptable ranges and minimums for these properties.
Water Leak Test: The "ground truth" is defined by the FDA 1000 ml water leak test protocol, specifically aiming to meet an Acceptable Quality Level (AQL) of 4.0 with an Inspection Level of S-4.
Biocompatibility (Modified Draize Test): The "ground truth" is the clinical observation of human subjects for the presence or absence of significant irritation or allergic contact dermatitis.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned or implied for this device.

Summary

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SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai 201611, PRC TEL: 86-21-5760-2752 FAX: 86-21-5760-1003

MAY 2 3 1997

K971423

Page 1 of 2

510 (k) Summary

Date of summary prepared: March 19, 1997

Applicant: l.

Shanghai Foremost Plastic Industrial Co., Ltd. Yan Li River Bridge East Che Xing Highway, Che Dun Town Songjiang County, Shanghai 201611 People's Republic of China Tel: 86 21 5760-2752 Fax: 86 21 5760-1003

1. Contact Person:
  Dr. Tiang S. Chang 1016 Seward Avenue Westfield, N. J. 07090 Fax: 908 233-0925 e-mail: tschang@earthlink.net Tel: 908 233-3571
1. Name of Device:
  Vinyl Patient Examination Gloves, Powdered
1. Device Description:
  Classified by FDA's General and Plastic Surgery Device Panel as Class I, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.
ર્ડ Intended Use
The applicant device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai 201611, PRC TEL: 86-21-5760-2752 FAX: 86-21-5760-1003

510 (k) summary continue.

page 2 of 2.

Comparison to Predicate Device 6.

Non-Clinical Performance data

Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000 ml water leak test for pin-holes.

Test		ASTM D5250-92	Applicant Device
Length (mm)
Size	S	Min. 230 mm	240 ± 5 mm
	M	Min. 230 mm	240 ± 5 mm
	L	Min. 230 mm	240 ± 5 mm
	XL	Min. 230 mm	240 ± 5 mm
Width (mm)
Size	S	85 ± 5 mm	87 ± 3 mm
	M	95 ± 5 mm	98 ± 3 mm
	L	105 ± 5 mm	106 ± 3 mm
	XL	115 ± 5 mm	114 ± 3 mm
Thickness (mm)
	Finger	Min. 0.05 mm	Min. 0.08 mm
	Palm	Min. 0.08 mm	Min. 0.11 mm
Physical PropertiesBefore Aging
	Tensile Strength (MPa)	Min. 9 MPa	Min. 10 MPa
	Ultimate Elongation (%)	Min. 300%	Min. 300%
After Aging
	Tensile Strength (MPa)	Min. 9 MPa	Min. 9.5 MPa
	Ultimate Elongation (%)	Min. 300%	Min. 300%
FDA Water Leak Test			Meets AQL 4.0 with aInspection Level of S-4

Clinical Performance Data

The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

7. Conclusions

The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000 ml Water Leak Test.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble human figures or abstract forms.

MAY 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Foremost Plastic Industrial Co, Ltd. C/O Mr. Robert Mosenkis ......... President ………… CITECH 5200 Butler Pike Plymouth Meetling, Pennsyvania 19462-1298

Re: K971423 Vinyl Patient Examination Glove, Powdered Trade Name: Requlatory Class: I Product Code: LYZ Dated: April 16, 1997 Received: April 17, 1997

Dear Mr. Mosenkis:

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 of the Act. 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.

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. ਖੇ 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. Mosenkis

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 $10(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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. 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

Direc 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 1 b

I İ of Page

Labels	Values
Number (if known):	KG711423

evice Name: Patient Examination Glove, Powdered

dications 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)

Olin S. Lim

(Division Sign-Off)
Division of Dagcul, Infection Control

Division of Danial, Infection Control. and General Hospital Devic 510(k) Number

ecription Use 21 CFR 801.109)

Over-The-Counter Use X

(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.