(47 days)
Laglove™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Brand Nitrile Examination Gloves (Powdered)
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for Laglove™ Brand Nitrile Examination Gloves (Powdered). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
The letter does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The document primarily focuses on the regulatory clearance for the gloves, stating their intended use and classification.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1999
Mr. G. Baskaran Managing Director Laglove (M) Sdn. Bhd. Lot 478, Jalan Simpang Balak, Off Batu 13, Jalan Cheras, 43000 Kajang, Selangor Darul Ehsan MALAYSIA
Re : K990415 Laglove™ Brand Nitrile Examination Trade Name: Gloves (Powdered) Regulatory Class: I Product Code: LZA Dated: February 8, 1999 February 10, 1999 Received:
Dear Mr. Baskaran
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. ਸੈ 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 regulation 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
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Page 2 - Mr. Baskaran
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 described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicatored wour 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 Itilo diagnobers at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Dfomocion and advereibing or Journal (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regaracion chorion" (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,
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 3.0
| Applicant | : LAGLOVE (M) SDN. BHD. |
|---|---|
| 510(k) number | : |
| Device name | : Laglove TM Brand Nitrile Examination Gloves (Powdered) |
Indications for use:
Brand Nitrile Examination Glove (Powdered) is a Laglove™ disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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10R
Over-The-Counter Use X
(Optional Format 1-2-96)
Chins. Lin
Division Signer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J
§ 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.