(48 days)
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Exam Gloves With Aloe Vera Green, contains 50 mcgm or less of total water extractable protein per gram
This is a letter about a medical device, specifically Textured Powder-Free Latex Examination Gloves With Aloe Vera Green. The letter is a 510(k) premarket notification approval from the FDA.
Based on the provided text, there is no study described that proves the device meets acceptance criteria. The letter is an approval letter based on substantial equivalence to a previously marketed device, not a detailing of a specific study or performance metrics.
Therefore, most of the requested information cannot be extracted from this document as it doesn't contain a detailed study report. Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion mentioned is the "Labeling Claim, Green Cortforms . 50 million on less prefern per gram" (likely a typo and meant to be "50 micrograms or less of total water extractable protein per gram").
- Reported Device Performance: The document only states that the device "conforms" to this claim. No numerical performance results from a specific test are provided within this letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in this document.
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
- Not applicable/Not specified in this document. This device is a glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified in this document. This device is a glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here would relate to the protein content testing. It's implied that a standardized chemical test method would have been used to determine the total water extractable protein per gram. No specifics are given.
8. The sample size for the training set
- Not applicable/Not specified in this document. This isn't a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not specified in this document.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
AUG 17 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Belle L. Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
RE: K992200 Trade Name: Textured Powder-Free Latex Examination Gloves With Aloe Vera Green,contains 50 mcgm or less of total water extractable protein per gram Class: I Product Code: LYY June 29, 1999 Dated: Received: June 30, 1999
Dear Ms. Chou:
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 reqistration, 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 Failure to comply with the GMP requlation may such assumptions. 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.
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Page 2 - Ms. Chou
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 xitro diaqnostic 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricio Cucarita Flor
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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Attachment Two
992200
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Textured Powder-Free Latex Exam Gloves with Aloe Vera and Protein Content .
Labeling Claim, Green Cortforms . 50 million on less prefern per gram
Indication For Use:
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Qun S. Lin
Concurrence of CDRH Office of Device Evaluation (ODE)
Division Sign-Off Division of Dental, Infection Control, and General Hospital De 510(k) Number
Prescription Use Per 21CFR 801.109 OR
Over-The Counter
(Optional Format 1-2-96)
5
§ 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.