(83 days)
Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding a Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove. This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.
The letter primarily:
- Confirms the FDA's review of the 510(k) submission (K014087).
- States that the device is substantially equivalent to legally marketed predicate devices.
- Informs the manufacturer that they can market the device subject to general controls.
- Outlines general regulatory compliance requirements.
- Provides contact information for further guidance.
- Includes a separate "Indications for Use" statement, which defines the intended purpose of the device.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is a regulatory clearance letter, not a performance study report.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely part of a document header or logo. The words are all capitalized and evenly spaced.
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or a wing-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 2002
Latexx Manufacturing Sdn. Bhd. C/O Ms. Yolanda Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
Re: K014087
Trade/Device Name: Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 11, 2001 Received: December 11, 2001
Dear Ms. Smith:
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.
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
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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I occeral bars sure quirements, including, but not limited to: registration 1 ou must comply with a807); labeling (21 CFR Part 801); good manufacturing practice and instill (21 es rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form 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 1 mis letter will and w you to began maint and 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 If you debare opening 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 nouthout (D. C. C. I I a 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): KOI 4087
Device Name: Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber
Coated, Polymer Coated, Co Latex Examination Glove
Classification Panel: 80LYY
Indications for Use:
Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device Non-chornated Powel Free Natural International of the healthcare and similar intended for medical purposes that is work on the hass of the patient.
personnel to prevent contamination between the healthcare personnel and the patient.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ____________________________ |
|---|---|
| or | Over-the Counter Use____________________________ |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| General Hospital Devices | |
| 510(k) Number | K014087 |
§ 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.