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

Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.

AI/ML Overview

This document (K992107) describes a submission for "GG" vinyl examination gloves, powder-free, from General Gloves Corp. It is a 510(k) summary, which indicates it's for claiming substantial equivalence to a legally marketed device rather than a de novo approval requiring extensive clinical trials.

Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the way one would expect for a novel medical device like an AI-powered diagnostic tool. Instead, it demonstrates compliance with a recognized standard and compares the device's characteristics to a predicate device.

Here's an analysis based on the provided text, addressing your points where applicable, and noting when the information is not present in this type of submission:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are generally derived from the ASTM D 5250 - 92 standard for patient examination gloves. The reported device performance is stated to meet or exceed these standards.

Acceptance Criteria (from ASTM D 5250 - 92)	Reported Device Performance (GG vinyl examination gloves powder-free)
Dimension and Tolerance (S-2, AQL 4.0)
Width (S)	85-87 mm (+5 to +3 tolerance)
Width (M)	95-97 mm (+5 to +3 tolerance)
Width (L)	105-107 mm (+5 to +3 tolerance)
Width (XL)	115-117 mm (+5 to +3 tolerance)
Length (all sizes)	230 mm min.
Physical Requirements (Before and after accelerated aging 70 + 2 C for 72 + 2 hours, acc. to D573; Inspection level S-2, AQL 4.0)
Ultimate Elongation (%, min)	300%
Tensil strength (Mpa, min)	9.0 Mpa
Pinhole requirements	Meets FDA pinhole requirements.
Biocompatibility	Data conducted on powdered vinyl gloves (presumably applicable or similar to powder-free version).
Labeling claims	Meets labeling claims.

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

The document mentions "inspection level S-2, AQL 4.0" for dimension/tolerance and physical requirements. These are sampling plans from standards, but the exact sample size (number of gloves tested from a batch) is not explicitly stated in the summary, as it depends on the lot size.

The data provenance is from Taiwan (Tung Chung Village, Tung Shan Hsian, Tainan Hsien, Taiwan, R.O.C.), where General Gloves Corp. is located. The tests would be considered prospective manufacturing quality control tests.

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

This information is not applicable and not provided for this type of device submission. Glove testing relies on standardized physical and chemical tests, not expert interpretation of outputs.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic studies. Glove testing involves objective measurements based on 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 submission for an examination glove, not an AI-powered diagnostic device.

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

This information is not applicable. This is a submission for an examination glove, not an algorithm.

7. The type of ground truth used

The "ground truth" here is compliance with the ASTM D 5250 - 92 standard for patient examination gloves and FDA pinhole requirements. This is based on objective, quantifiable physical and chemical properties of the gloves.

8. The sample size for the training set

This information is not applicable. This is a physical product (glove), not a machine learning algorithm that requires a training set.

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

This information is not applicable. As above, it's not an AI/ML device requiring a training set. The "ground truth" for glove quality is established by adherence to a recognized international standard (ASTM D 5250 - 92).

Summary

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K992107

TM ERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733, R. O. C.

510 (k) SUMMARY) [As required by §807.92(c)]

Submitter's name and address: HTI Trading Group 1) . 3423 Investment Blvd. Suite 12 Hayward, CA 94545

Telephone and Fax numbers of submitter:

510-732-9623 Tel: Fax: 510-732-9716

AUG 2 3 1999

David Hu, Ph.D., President Contact person:

Date summary prepared: June 21, 1999

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K992107

GENERAL GLOVES CORP.

通用手套國際股份有限公司

T M

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.

2).	Trade name: "G G" vinyl examination gloves powder-free
	Common name: Exam gloves
	Classification name: Patient examination glove(per 21 CFR 880.6250)
3).	Legally marketed device: Class I vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.
4).	Description of the device: Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.
5).	Intended use of device: 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.
6a).	Technological characteristics compared to ASTM standard D 5250 - 92:
	Dimension and tolerance (S-2, AQL 4.0)
		S	M	L	XL	Tolerance
	width	8587	9597	105107	115117	+5+3	ASTM D 5250(General)

230 230 length 230 230 min. ASTM D 5250 230 230 230 230 min. (General)

Biocompatability data are conducted on the powdered vinyl gloves .

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K992107

ERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.

Physical requirements 6a) .
Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. (Inspection level S-2, AQL 4.0)

Ultimate Elongation (%, min) Tensil strength (Mpa, min) 300 9.0

Assessment of performance data (non-clinical tests): 6b(1) . .
The performance test data is the same as for 807.92(a)96) mentioned immediately above.
Assessment of performance data (clinical tests) : 6b(2) . Not required.
Our gloves meet or exceed the ASTM or equivalent standard. 6b(3) . Our gloves meet FDA pinhole requirements.

Our gloves meet the labeling claims as shown by the data in (a) (6) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal 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, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 1999

General Gloves Corporation C/O Mr. David Hu, Ph.D. President HTI trading Group 3423 Investment Boulevard # 12 Hayward, California 94545

Re : K992107 Baldur Brand Vinyl Powdered Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: June 21, 1999 Received: July 01, 1999

Dear Mr. Hu:

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 Regulations, Title 21, Parts 800 to 895. A 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 successful in regulatory action. In addition, FDA may publish further Please note: this response to your premarket notification submission does not affect any 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.

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Page 2 - Mr. Hu

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 Ehus, 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 Additionally, for questions on the promotion and (301) 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 Other general information on your responsibilities CFR 807.97). 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy Ulatowsk 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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GENERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 16 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.

STATEMENT OF INDICATIONS FOR USE [807.92(a) (5) ] .

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

(PLEASE) DO MOX WRITERBELOM:THIS-LINE-CONTINUE-ON-ANGTHER®PAGE · · · · · IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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

Olin S. Lin

on Sign-Off) sion of Dental, Inte i General Ho 510(k) Numb

T M

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.