(91 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Powder Free, Pink Color
This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Powder Free, Pink Color." It states that the device is substantially equivalent to legally marketed predicate devices.
The information provided in the document does not contain details about acceptance criteria, device performance, study types, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device in a clinical or diagnostic context.
Instead, the document primarily focuses on the regulatory approval process for a patient examination glove, confirming its substantial equivalence to predicate devices for its intended use (preventing contamination between patient and examiner). The "Indicators For Use" section defines the product, but does not specify performance metrics.
Therefore, I cannot provide the requested information based on the input text. The text is a regulatory approval letter, not a performance study report.
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Image /page/0/Picture/1 description: The image shows a circular logo with the words "U.S. Department of Health & Human Services" encircling a stylized symbol. The symbol consists of three curved lines that resemble a bird in flight or a flowing ribbon. The logo is black and white and appears to be a seal or emblem.
Public Health Service
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linga Sumarta Arista Latindo Industrial, Limited P.T. JL: K.H.MOH Mansyur No 128 Jakarta 11210 INDONESIA
Re: K031944
Trade/Device Name: Vinyl Examination Gloves Powder Free Pink Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 23, 2003 Received: August 28, 2003
Dear Ms. Sumarta:
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 -Ms. Sumarta
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 practice requirements 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.
Susan Runner
Susan Runner, DDS, MA Interim 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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Image /page/2/Picture/0 description: The image shows the logo for Arista Latindo Industrial LTD. P.T, a glove manufacturer. The logo features a stylized symbol on the left, resembling a circle with a triangle inside. To the right of the symbol is the company name in bold, block letters, with the words "GLOVE MANUFACTURER" underneath in a smaller font.
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Section No. 3.
ATTACHMENT #2
INDICATIONS FOR USE STATEMENT
| Applicant: | PT. ARISTA LATINDO IND. LTD. |
|---|---|
| 510(k) Number (if known): | K031944 * |
| Device Name: | Vinyl Examination Gloves, Powder Free, Pink Color |
| Indications For Use: |
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031944
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use. Per 21 CFR 801.109 OR
Over-The-Counter______________________________________________________________________________________________________________________________________________________________
(Optimal Format 1-2-96)
§ 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.