(36 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Basic Non-Sterile, Powder-Free Latex Examination Gloves
This is a challenging request as the provided text is a medical device clearance letter from the FDA (K991849), not a scientific study or a performance report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document grants clearance for a device based on substantial equivalence to a predicate device, not on meeting specific, quantifiable performance metrics through a new study as you've outlined.
Here's a breakdown of why I cannot fulfill the request with the given input and what information is present:
Information NOT present in the document:
- A table of acceptance criteria and the reported device performance: This document doesn't define or report on specific performance criteria (e.g., sensitivity, specificity, accuracy) for the new device. Its clearance is based on comparison to an existing device.
- Sample sized used for the test set and the data provenance: No new testing data is presented.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable, as no new study with ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is a physical glove, not an algorithm).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: "Non-Sterile, Power-Free Latex Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extractable Protein)" and trade names "Cashmere Non-Sterile, Powder-Free Latex Examination Gloves" and "Basic Non-Sterile, Powder-Free Latex Examination Gloves."
- Indications For Use: "This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment."
- Regulatory Class: Class I
- Product Code: LYY
- Key claim: "50 Micrograms or Less Total Water Extractable Protein" (This is a specific characteristic, but not a performance metric like sensitivity or specificity).
- Regulatory Mechanism: 510(k) clearance based on substantial equivalence to predicate devices marketed before May 28, 1976. This explicitly states that the device is considered equivalent, not that it has passed a new, detailed performance study with quantifiable criteria.
In summary: The provided FDA letter is a regulatory approval document and does not contain the detailed study results and acceptance criteria typically found in a scientific paper or a device's performance validation report. Therefore, I cannot extract the requested information from this text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -7 1999
Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak MALAYSIA
Re : K991849 Non-Sterile Power-Free Latex Examination Trade Name: Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extractable Protein) Requlatory Class: I Product Code: LYY May 26, 1999 Dated: Received: June 1, 1999
Dear Mr. Chan Chin Hong:
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, qood 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chan Chin Hong
this response to your premarket notification Please note: Frease note: oneot affect any obligation you might have under sections 531 through 542 of the Act for devices under the Sections 351 chicagon Federal laws or regulations.
This letter will allow you to begin marketing your device as fire ibed in your 510(k) premarket notification. The FDA described in your sia wequivalence of your device to a legally rinang or edicate device results in a classification for your markees promits 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprimee as (od advertising of your device, please contact che promocion analiance at (301) 594-4639. Also, please note ene orrios or entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of Job Division of Small Manufacturers Assistance obtained from cle bribers (800) 638-2041 or (301) 443-6597 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 Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
K991849 510(K) Number :
: Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Device Name Basic Non-Sterile, Powder-Free Latex Examination Gloves
Indication For Use:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)
Prescription Use: ... .. Per 21 CFR 80.109
OR Ove
Over-The-Counter X
Chun S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital I 510(k) 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.