A 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.

Device Description

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

AI/ML Overview

I apologize, but the provided text from the FDA letter (K990117) does not contain any information about acceptance criteria, device performance metrics, or study details.

This document is a 510(k) clearance letter for "Disposable Vinyl Synthetic Exam Gloves, Powder-Free." It states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. The letter primarily addresses:

Device Identification: Disposable Vinyl Synthetic Exam Gloves, Powder-Free.
Regulatory Classification: Class I, Product Code LYZ.
Regulatory Pathway: 510(k) clearance based on substantial equivalence.
Indications for Use: "A 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."
General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
No clinical study data or performance metrics are detailed in this document.

Therefore, I cannot fulfill your request for:

Table of acceptance criteria and reported device performance: Not present.
Sample sizes, data provenance: Not present for performance testing.
Number of experts, qualifications: Not applicable, as no expert review of performance data is mentioned.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not present.
Standalone performance: Not present for this type of device and clearance.
Type of ground truth: Not applicable.
Training set sample size: Not applicable.
Ground truth for training set: Not applicable.

This document serves as regulatory clearance based on substantial equivalence, not as a detailed clinical study report or performance validation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be interconnected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1999

Mr. Danny Wang Sales Manager Shanghai Palomar Mountain Industries, Incorporated #1 BIYU Road Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.

K990117 Re : Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powder-Free Requlatory Class: I Product Code: LYZ October 28, 1998 Dated: Received: January 11, 1999

Dear Mr. Wang

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Wang

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 described in your sivin, promazince 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 vitro diaqnostic 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 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

Timc Ulato Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

INDICATIONS FOR OSE
Applicant: SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.

990117 510(k) Number (if known): *

Device Name: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE Indications For Use:

A 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.

رم

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)

Over-The-Counter X

For a new submission, do NOT fill in the 510(k) number blank.

Chiên S. Lin

(Division n-069
Divisons Infection Contr
and Gon Hospital De lees
510(k) Number. K990117

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.