(128 days)
A patient Examination Powder-Free Polymerisation 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.
Patient Latex Examination "Powder-Free" Trade Name: Polymer Coated Gloves
The provided document is a 510(k) premarket notification letter from the FDA regarding "Patient Latex Examination 'Powder-Free' Polymer Coated Gloves" by Wear Safe Malaysia Sdn. Bhd.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of medical device validation for performance or effectiveness.
Instead, the letter:
- Confirms that the device is substantially equivalent to legally marketed predicate devices.
- Allows Wear Safe Malaysia Sdn. Bhd. to market the device subject to general controls provisions of the Act.
- Provides information on regulatory compliance (GMP regulations, labeling, promotion, and advertising).
Therefore, I cannot extract the requested information from this document. The sections you asked for, such as:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- 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
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
are not present in this regulatory correspondence. Such details would typically be found in the 510(k) submission itself (which includes test reports, studies, and data) but are not generally summarized in the FDA's decision letter.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 6 1999
Ms. Danielle Cottet Ouality Controller Wear Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu North Klang Straits Industrial Area 42000 Port Klang Selangor Darul Ehsan, West Malaysia
Re: K992676 Patient Latex Examination "Powder-Free" Trade Name: Polymer Coated Gloves Requlatory Class: I Product Code: LYY Dated: November 24, 1999 December 2, 1999 Received:
Dear Ms. Cottet:
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. 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
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Page 2 - Ms. Cottet
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 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 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 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 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,
Susan Dunne
for 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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Image /page/2/Picture/0 description: The image shows the logo for Wear Safe Malaysia (WSM). The logo has the letters WSM in large bold font, with the words "WEAR SAFE MALAYSIA" underneath. To the right of the letters is a symbol that looks like a plus sign, and the words "SDN. BHD. (204396-X)" are to the right of the symbol. The text underneath the logo says "(Formerly known as WUHRLIN SOPLAMED (M) SDN. BHD.)"
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K992676 510 (k) Number (if known) : PATIENT EXAMINATION "POWDER-FREE" GLOVES Device Name : Indications For Use :
- A patient Examination Powder-Free Polymerisation 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)
Presription Use
OR
Over-The -Counter Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
Olin S. Lin
"Wision Sign-Off) ion of Dental, Infection Control, General Hospital · · Number _
§ 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.