DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

• K Number: K992128
• Device Name: DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
• Manufacturer: DASH MEDICAL GLOVES SDN BHD
• Date Cleared: 1999-09-14 ( 83 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

Device Description

Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less); VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)" and "VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves."

This document does not contain any information about acceptance criteria or a study proving device performance. It is an FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. The letter discusses regulatory classifications, general controls, and compliance requirements, but not specific performance metrics or study results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

Summary

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Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 14 1999

Dash Medical Gloves Sdn. Bhd. c/0: Mr. Robert J. Sullivan Jr. President Dash Medical Gloves, Incorporated 10180 South 54th Street Franklin, Wisconsin 53132

K992128 Re : Dash Siliconized Polymer Coated Powder Free Trade Name: Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)/VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves Requlatory Class: । Product Code: LYY June 9, 1999 Dated: Received: June 23, 1999

Dear Mr. Sullivan:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੋ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined lines forming a shape reminiscent of a bird or a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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Page 2 -Mr. Sullivan

obligation you might have under sections 531 through 542 of obligation you might have ahabi betronic Product Radiation che Act for devioes andorher Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marroos 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 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please gontact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/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 Radioloqical Health

Enclosure

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: ::

510(k) Number (if known): K992128

Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Device Name: Content Labeling Claim (50 micrograms or Less)

VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves 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.

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

Concurrence of CDRH/Office/of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K992178

Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use √

(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.