(70 days)
POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS)
This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves W/Protein Trade Name: Labeling (100 Micrograms or Less Per Gram)". This type of regulatory submission is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.
The information provided does not contain details about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-powered device.
Instead, the letter indicates that the device has been found substantially equivalent to predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, they do not raise different questions of safety and effectiveness.
Here's what can be inferred from the document regarding the device and its regulatory status, and why it doesn't provide the requested information:
- Device Type: Powdered Latex Examination Gloves with Protein Labeling (100 Micrograms or Less)
- Regulatory Class: I (General Controls)
- Product Code: LYY
- Intended Use: "POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT."
Why the requested information is absent:
The questions you've asked (about acceptance criteria tables, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are typically associated with the evaluation of diagnostic devices, AI/ML-driven software, or devices with measurable performance outcomes that require clinical validation studies to demonstrate safety and effectiveness.
For a Class I device like examination gloves, the "acceptance criteria" for 510(k) clearance primarily revolve around demonstrating substantial equivalence to a predicate device. This usually involves:
- Same Intended Use: As stated in the document.
- Similar Technological Characteristics: This would involve comparing material, design, manufacturing processes, and performance specifications (e.g., tensile strength, barrier integrity, protein content for label claims) to a predicate device.
- Meeting Recognized Standards: Often, these devices must meet specific ASTM or ISO standards for medical gloves (e.g., ASTM D3578 for medical examination gloves).
- Labeling: The label claims, particularly regarding protein content (100 micrograms or less per gram), are a key aspect and would need to be supported by testing.
The "study that proves the device meets the acceptance criteria" for a glove would likely be a series of non-clinical bench tests (e.g., integrity testing, physical properties testing, protein content assays) showing compliance with relevant standards and the advertised protein level, rather than clinical trials with human subjects or expert consensus.
Therefore, I cannot provide the requested table and detailed study information because this document (a 510(k) clearance letter for examination gloves) does not contain that type of data. It confirms regulatory clearance based on substantial equivalence, but not the specific performance metrics and validation study details you'd find for more complex diagnostic or AI-enabled devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Mr. Wee Chai Lim Director Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru 41050 Klang, Selangor D.E. MALAYSIA
Re: K990468 Powdered Latex Examination Gloves W/Protein Trade Name: Labeling (100 Micrograms or Less Per Gram) Requlatory Class: I Product Code: LYY February 11, 1999 Dated: February 16, 1999 Received:
Dear Mr. W.C. Lim:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. W.C. Lim
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other qeneral 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/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
Enclosure
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1
0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The formation, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | TOP GLOVE SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K990468 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS) |
Indications For Use:
: :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and and submitted and the film the first in the lands in the first in the first in the first in the first in the first in the first in the first in the first in the first in
POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
(PLEASE DO NOT WRITE BELOW TINS LINE - CONTINUE ON AND THER PAGE 11 NEBULU)
Concurrence of CDRH Office of Dovice Evaluation (ODE)
Chin S. Lim
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
OR
Over-the-Counter
Prescription Une Por 21 CFR 801.109 ()[{{
(Optional Formal 1-2-96)
· For a new submission, do NVT fill in the 510(k) number blank.
§ 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.