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, Vinyl Patient Examination Glove, Powder-free, 80L YZ, conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

AI/ML Overview

The provided text describes the acceptance criteria and study results for "Vinyl Patient Examination gloves, Powder-free" by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (ASTM D5250-92)	Reported Device Performance (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 Properties
Before 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	(Implicit from ASTM D5250-92)	Meets AOL 4.0 with Inspection Level of S-4
Modified Draize Test	Not specified (clinical significance)	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:

Test Set Sample Size: The document does not explicitly state a specific sample size for each performance test (e.g., number of gloves tested for dimensions, tensile strength, or water leak). For the Modified Draize Test, it mentions "human subjects," but no specific number.
Data Provenance: The document does not specify the country of origin of the data. It mentions the applicant is in Shanghai, China, but this doesn't confirm the test location. The study type appears to be prospective, as the testing was done specifically for this submission.

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):

This information is not applicable as the device is a physical medical device (gloves), not an AI/diagnostic device that requires expert ground truth establishment for interpretation. The "ground truth" is based on objective measurements and established standards (ASTM D5250-92 and FDA water leak test). For the Modified Draize Test, the interpretation of irritation and allergic contact dermatitis would be done by qualified medical professionals, but their number and specific qualifications are not detailed.

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

This information is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving subjective interpretation, like image analysis or clinical endpoint assessment. The tests performed are objective measurements against established standards.

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 information is not applicable. This is a physical medical device (gloves), not an AI or diagnostic tool involving human readers or AI assistance.

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

This information is not applicable. This is a physical medical device (gloves), not an algorithm or AI system.

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

The ground truth for the dimensional, physical properties, and water leak tests is based on pre-defined engineering and performance standards (ASTM D5250-92 and FDA 1000 ml water leak test). These are objective, measurable criteria.
For the Modified Draize Test, the ground truth relates to the absence of clinically significant irritation or allergic contact dermatitis in human subjects, as interpreted by medical professionals.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process.

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: 86-21-5760-0245 FAX: 86-21-5760-1003

K971615
510 (k) SUMMARY
MAY 23 1997 Page 1 of 2

Date of summary prepared: March 25, 1997

3 11 11 11 11 11 1586

l. Applicant:
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

Name of Device 3.

Vinyl Patient Examination gloves, Powder-free

Device Description: 4.

1. 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: 86-21-5760-0245 FAX: 86-21-5760-1003

510 (k) summary continue.
page 2 of 2.

Inspection Level of S-4

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

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 Properties
Before 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 AOL 4.0 with

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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・一

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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, Pennsylvania 19462-1298

Re : K971415 Vinyl Patient Examination Glove, Powder-Free Trade Name: Regulatory 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro 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

Timot Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Altachment I b

1 of 1 Page

510(k) Number (if known): KG71415

Device Name: Patient Examination_Glove, Powder-Free

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)

Qhin S. Lin

(Division Sign. Division of Det. Control. and General Hospital Devices 510(k) Number

scription Use Jr 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 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.