(64 days)
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Here's a breakdown of the acceptance criteria and study information for the "POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Physical Properties | |
| Tensile Strength (Unaged) | 21.0 MPa (Minimum 14 MPa) |
| Tensile Strength (Aged) | 18.2 MPa (Minimum 14 MPa) |
| Elongation at Break (Unaged) | 600% (Minimum 500%) |
| Elongation at Break (Aged) | 500% (Minimum 400%) |
| Barrier Integrity | |
| Freedom from Holes (AQL 2.5) | AQL 2.5 |
| Biocompatibility | |
| Dermal Sensitization | Non-sensitizing |
| Primary Skin Irritation | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the "test set." However, it references established industry standards:
- Tensile Strength & Elongation: Tested according to ASTM D412.
- Freedom from Holes: Tested according to ASTM D5151 (Water Leak Test) and FDA 21 CFR 800.20 (Acceptance Quality Limit - AQL). The AQL of 2.5 implies a sampling plan based on lot size, which dictates the number of units to be inspected and the maximum allowable number of failures.
- Biocompatibility: Tested according to ISO 10993-10 (Dermal Sensitization and Primary Skin Irritation).
The data provenance is not explicitly stated in terms of country of origin for the performance tests, but the manufacturer is "Comfort Rubber Gloves IND. SDN. BHD." from Malaysia. The tests are prospective in nature, as they are performed on the device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective, standardized measurements and laboratory assessments, not by expert consensus or interpretation of images. For example, tensile strength is measured quantitatively, and freedom from holes is determined by a physical water leak test.
4. Adjudication Method for the Test Set
This information is not applicable. The performance criteria for patient examination gloves are based on objective physical and chemical testing, not on adjudicated readings or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not applicable and therefore not done. This type of study is relevant to AI/diagnostic imaging devices where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a physical medical device (examination glove), and its performance is assessed through standardized laboratory tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical product, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on:
- Objective physical measurements: For tensile strength and elongation.
- Adherence to established quality limits: For freedom from holes (AQL 2.5).
- Standardized laboratory biological assays: For dermal sensitization and primary skin irritation (ISO 10993-10).
Essentially, the "ground truth" is defined by the performance requirements outlined in the relevant ASTM, FDA, and ISO standards that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable. The device is a manufactured product, not an AI model that requires a "training set." Its performance is directly assessed through testing of manufactured samples.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2009
Comfort Rubber Gloves IND. SDN. BHD. Mr. Tan K. Beng Managing Director Lot 821, Jalan Matang, 34750 Matang Taiping, Perak MALAYSIA
Re: K083624
Trade/Device Name: Powder Free Nitrite (Blue and White) Examination Gloyes Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 19, 2009 Received: January 26, 2009
Dear Mr. Beng.
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 – Mr. Beng
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. onaton for
Ginette Y. Michaud, M.D.
Acting 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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INDICATIONS FOR USE
Comfort Rubber Gloves Ind. Sdn. Bhd. Applicant
510(k) Number (if known): KO83624
Device Name: POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Indications for Use:
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 10(k) Number: | K083624 |
|---|---|
| --------------- | --------- |
§ 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.