(42 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves With Peppermint Scented (Blue Color)
The provided document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves with Peppermint Scented (Blue Color)." This document is a regulatory approval letter for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria.
The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the new device to existing devices that have already been cleared. For devices like examination gloves, the substantial equivalence typically involves demonstrating similar materials, performance characteristics (e.g., barrier integrity, tensile strength), and intended use as the predicate device, rather than a clinical study as would be required for more complex devices.
Therefore, I cannot provide the requested information, as it is not present in the given text.
To answer your specific questions in the context of what would typically be part of a submission for such a device, but which are not detailed in this specific letter:
- A table of acceptance criteria and the reported device performance: Not provided in the document. For examination gloves, acceptance criteria would typically relate to physical properties like tensile strength, elongation, force at break, viral penetration, and freedom from holes, often adhering to international standards (e.g., ASTM D6319 for Nitrile Examination Gloves).
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context would typically refer to laboratory test results.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic devices or AI algorithms where human interpretation is involved.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
- The type of ground truth used: Not explicitly stated, but for examination gloves, "ground truth" refers to laboratory measurements of physical and barrier properties against established standards.
- The sample size for the training set: Not applicable; this device does not involve machine learning.
- How the ground truth for the training set was established: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents around a staff.
Public Health Service
JUL 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. So Soon Cheaw General Manager Platinum Glove Industries Sdn Bhd 4015A, 4 Floor, President House, Jalan Sultan Ismail, 50250 Kuala Lumpur, MALAYSIA
Re: K051372
KUJ1572
Trade/Device Name: Powder Free Nitrile Examination Gloves with Peppermint Scented (Blue Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 21, 2005 Received: May 27, 2005
Dear Mr. Cheaw:
We have reviewed your Section 510(k) premarket notification of intent to market the device we flave reviewed your becalent o (~) the device is substantially equivalent (for the similaries may indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use surced in the enactment date of the enactment date of the Medical Device interstate conments, 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 the Federal Food, Drug, and Cosmetic Pro (Pro) ------------------------------------------------------------------------------------------------------------------------------approval application (1 Mr.). - Four Rey, controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, lection. In 10 for hibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see abouter into controls. Existing major regulations affecting (PMA), it may of Subject to Such address. Title 21, Parts 800 to 898. In the Coders your device can be found in the Code of Peacharing your device in the Federal Register.
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Page 2 - Mr. Cheaw
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I Dri is issualled on that your device complies with other requirements theat that IDA has made a determind regulations administered by other Federal agencies. of the Act of ally I cucral statues and reguirements, including, but not limited to: registration You must comply with and no hotel brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), laceling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (Sections (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) I ins letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDA miding of basicines of basice 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), If you desire specific advice for your do roll of the more of the regulation please contact the Other or Ochiphan or an executive (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain other general miornalional and Consumer Assistance at its toll-free Division of Dinas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement: 3.0
INDICATIONS FOR USE
510(k) Number (if known) :
Device Name:
Powder Free Nitrile Examination Gloves With Peppermint Scented (Blue Color)
Indication For Use:
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
× Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
S/ A.M. doncurrence of Office Of Device Evaluation (ODE)
esiology, General Hospital,
510(k) Number: K051372
§ 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.