A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.

Device Description

8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with beaded cuff extending beyond the wrist.

AI/ML Overview

This document does not contain information about an AI/ML device or a study comparing AI with human readers. The document is a 510(k) summary for Sage Nitrile Gloves, a medical device (examination glove), submitted to the FDA in 1997. It describes the device, its intended use, a substantial equivalence comparison to other gloves, and lists performance tests conducted according to various ASTM and FDA standards for physical properties and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, comparative effectiveness, standalone performance, ground truth, or training set details as this information is not present in the provided text.

Summary

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AUG 25 1997

Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K970135'. The characters are written in a simple, slightly irregular style, with varying stroke thicknesses.

510(k) Summary for Sage Nitrile 14

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 90.

Submitter Name	Karen Pinto, Regulatory Affairs Manager
Company Name	Sage Products Inc.
Street Address	815 Tek Drive, Crystal Lake, IL 60014
Contact Person	Karen Pinto, Regulatory Affairs Manager
Telephone of Contact Person	815-455-4700 ext. 1383
Fax of Contact Person	815-455-5599
Date of Summary Preparation	May 8, 1997
Device Name
Trade or Proprietary Name	Nitrile Gloves (POWDER FREE, EXAMINATION GLOVE)
Classification Name	Patient Examination Gloves (CFR: 800.6250)
Common Name	Exam Gloves
Indications for Use	A medical glove worn on the hand of a healthcare worker andsimilar personnel to prevent contamination between healthcarepersonnel and patient. In addition, this glove is worn for theprotection of the wearer against exposure to chemotherapeuticagents.
Description:	8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves withbeaded cuff extending beyond the wrist.

Page 13 of 16

Response to 8/19/1997 Request for Revisions

"Innovative health care products since 1971"

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Image /page/1/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white and features a bold, sans-serif font. The word "SAGE" is in large letters, and the words "PRODUCTS INC" are in smaller letters below. There is a line above the word "PRODUCTS" and below the word "INC".

510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) 14

Substantial Equivalence Comparison

ProductName	NitrileGloves	Safeskin	Nitrex	N-Dex	N-Dex	N-Dex
Manufac-turer	SageProducts, Inc.	Safeskin	Delta HospitalSupply, Inc. orDelta MedicalSystems	Best	Best	Best
Product Code	Undetermined	N-110	UNT-100	8005	9005	9905
K Number	Has not beenassigned yet	Could notlocate	Could notlocate	Could notlocate	K902696	K915086
Address	Crystal Lake,IL	San Diego,CA	Norwood,Mass orDuluth, GA	Menlo, GA	Menlo, GA	Menlo, GA
Intended Useof Product	Patientexaminationand personalprotection	Patientexaminationand personalprotection	Patientexaminationand personalprotection	Personalprotection,Food andPharmaceutical	Patient examination,personal protection,Food andPharmaceutical	Patient examination,personal protection,Food andPharmaceutical
Sizes available	xs, s, m, l , xl	xs, s, m, l,xl	s, m, l, xl	s, m, l, xl	s, m, l , xl	s, m, l , xl
Material	Nitrile	Nitrile	Nitrile	Nitrile	Nitrile	Nitrile
Orientation	Fitted andAmbidextrous	Ambidex-trous	Ambidextrous	Ambidextrous	Fitted	Ambidextrous
Cuff	Beaded	Beaded	Beaded	Beaded	Beaded	Beaded
Color	White	Blue	Blue	Blue	Blue	Blue
Product Code	Undetermined	N-110	UNT-100	8005	9005	9905
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
Length (in.)	12	9 1/2	11	9 1/2	11	11
FingertipThickness(mil)	8	6	6	8	6	6
Presence ofDonningPowder	No	No	No	Yes	Available with andwithout	Available with andwithout

Page 14 of 16

Response to 8/19/1997 Request for Revisions

"Innovative health care products since 1971"

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Image /page/2/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white and features the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. A horizontal line is placed above the phrase "PRODUCTS INC".

510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) 14

Performance Test Summary

The Sage nitrile glove have been tested per the following standards

21 CFR 800.20 .
. ASTM D412
ASTM 1342-91 .
ASTM 739-91 .
NFPA 1999 .
Blue Book Memorandum #G95-1, Sensitization, and Primary Irritation Testing .

Page 15 of 16

Response to 8/19/1997 Request for Revisions

"Innovative health care products since 1971"

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized abstract symbol resembling an eagle or a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Pinto Requlatory Affairs Manager Sage Products Incorporated 815 Tek Drive P.O. Box 9693 60014-9693 Crystal Lake, Illinois

AUG 25 1997

Re : K970135 Saqe Powder-Free Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZC Dated: May 23, 1997 Received: June 3, 1997

Dear Ms. Pinto:

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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Pinto

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 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.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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101 ﺴﻮ Page

510(k) Number (if known):	K970135
Device Name:	Sage Nitrile Gloves (POWDER FREE EXAMINATION GLOVE)

Indications For Use:

[Secrion 15, page 16 of 16, Pre-Market Notification: Nitrile Gloves]

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chis S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 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.