(28 days)
A 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.
Powder-Free, Latex Patient Examination Glove With Protein Labeling Claim. (contain 200 microgram or less of total water extractable protein per gram glove).
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a "Powder-Free, Latex Patient Examination Glove with Protein Labeling Claim."
The text focuses on:
- The FDA's determination of substantial equivalence to a legally marketed predicate device.
- Regulatory classifications and requirements for general controls (registration, labeling, good manufacturing practice).
- Contact information for various FDA offices.
- The intended use of the device.
There is no information within the provided text about:
- Specific acceptance criteria for device performance.
- Details of any study conducted to demonstrate the device meets performance criteria (such as sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance).
- Reported device performance metrics.
The document states a "Protein Labeling Claim: Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Glove," which is a characteristic of the device, but it does not present this as an "acceptance criterion" in the context of a performance study with reported results. The 510(k) process primarily assesses substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies for low-risk devices like gloves.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2002
Mr. Tan Kong Chang Executive Director Perusahaan Getah Asas Sdn Bhd Lot 754, Jalan Haji Sirat, Off Jalan Kapar, P.O. Box 188, 41720 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K023262
Trade/Device Name: Powder-Free, Latex Patient Examination Glove with Protein Labeling Claim, Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 27, 2002 Received: September 30, 2002
Dear Mr. Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Chang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim other A. Ulvestad
Timo hy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 3
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Page 1 of 1
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| 510 (K) Number (if known) | K023262 |
|---|---|
| Device Name | Powder-Free, Latex Patient Examination GloveWith Protein Labeling Claim.(contain 200 microgram or less of total water extractable protein per gram glove). |
:
Indications For Use
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH , Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K023262 |
|---|---|
| ---------------- | --------- |
§ 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.