(66 days)
A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.
Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
The document describes the acceptance criteria and performance data for Innovative Gloves Company Limited's Nitrile Examination Gloves Powder-Free (Black Color).
This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical trials with independent ground truth establishment or MRMC studies. The "study" here refers to the testing performed against recognized standards.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Non-Clinical Tests | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Physical Properties | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Powder Free | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Clinical Tests | Standard | Acceptance Criteria | Reported Device Performance |
| Skin Irritation Study | ISO 10993, Part 10:2002(E) | Meets ISO 10993, Part 10:2002(E) | Meets |
| Skin Sensitization Study | ISO 10993, Part 10:2002(E) | Meets ISO 10993, Part 10:2002(E) | Meets |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of participants for skin irritation). It only states that the device "Meets" the specified standards. ASTM and ISO standards for medical gloves typically specify sampling plans and test methods, but the raw data or detailed sample sizes are not provided in this summary.
- Data Provenance: The tests were conducted by Innovative Gloves Company Limited, based in Thailand. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with the relevant standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable in the context of this device and report. The "ground truth" here is adherence to established international and national standards (ASTM and ISO) for physical properties and biocompatibility. There isn't an "expert consensus" in the way one would establish ground truth for an AI diagnostic algorithm for image interpretation. The standards themselves define the criteria for "ground truth" performance.
4. Adjudication Method for the Test Set
- Not applicable. The tests are laboratory-based and objective measurements against established standard specifications, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
- Not applicable. This device is a physical product (a glove), not an algorithm.
7. Type of Ground Truth Used
- The ground truth for this device's performance is established by the specifications and methodologies outlined in the referenced international standards (ASTM D 6319-00a and ISO 10993, Part 10:2002(E)). These standards define acceptable ranges for dimensions, physical properties, pinhole freedom, powder content, and biological reactivity.
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is controlled, and quality control tests (which are the "performance" data here) are done on samples from production batches.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical medical device like a glove.
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Image /page/0/Picture/0 description: The image shows the logo and contact information for Innovative Gloves Co., LTD. The logo features a stylized "IG" with a hand above the "I". The text below the logo includes the company name, address (Sanambin-BanKlang Rd., Tambon Kuanlang, Amphur Hatyai, Songkhla 90110 THAILAND), telephone numbers (TEL: (66) 7424 0132, 424 0185, 7424 0195), and fax numbers (FAX: (66) 7424 0233, 7447 4734).
6 2009 MAR
LAND.
K083908
Summary of Safety And Effectiveness
A. Information
-
- Submitter's
Name:
- Submitter's
Address:
Innovative Gloves Company Limited.
830 Moo 4, Sanambin -Banklang Road Kuanlang, Hatyai, Songhkla 90010, THAILAND
Telephone Number: Fax
Contact person:
- Name of Device
Trade Name:
Device Class: Device Name:
(6674) 240132, 240195 , (6674) 240233, 474734
Mr. Rajeev Sood
Nitrile Examination Gloves Powder-Free (Black Color). 510K Number: K083908 Class I Patient examination gloves - 21 CFR 880.6250 Device Black Nitrile Powder free Examination Gloves
- Predicate Device:
Nitrile Examination Glove Powder-Free 510K Number: K993325
4. Description of device
Black Nitrile Powder-Free Medical Examination
Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
5. Statement of intended use,
This is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between the patient and the examiner.
Powder-Free examination gloves are suitable in situations where powder is not desirable.
- Explanation of similarities or differences to predicate device
The proposed device is identical to the predicate device except for the following: The proposed device has been rendered black instead of natural color (510K Number: K993325)
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INNOVATIVE GLOVES CO., LTD. Sanambin-BanKlang Rd., Tambon Kuanlang, Amphur Hatyai, Songkhla 90110 THAILAND. TEL: (66) 7424 0132, 424 0185, 7424 0195 FAX: (66) 7424 0233, 7447 4734
B) Performance
| Non-Clinical Tests | Standard | Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets |
| Powder Free | ASTM D 6319-00a | Meets |
| Clinical Tests | Standard | Performance |
| Skin Irritation Study | ISO 10993, Part 10:2002(E) | Meets |
| Skin Sensitization Study | ISO 10993, Part 10:2002(E) | Meets |
C) Conclusion
The Nitrile Examination Gloves Powder-Free (Black Color) has been carefully compared to a legally marketed device in the 510(k). The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective powder free medical glove.
Mohit
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rajeev K. Sood President & CEO Innovative Gloves Company, Limited 830 Moo 4, Sanambi-Ban Klang Road Kuanlang, Hatyai Songkhia 90110 THAILAND
6 2009 MAR
Re: K083908
Trade/Device Name: Nitrile Examination Gloves Powder-Free (Black Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: February 17, 2009 Received: February 17, 2009
Dear Mr. Sood:
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. Sood
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 (OS) 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.
Chistrony D. Willion
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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E GLOVES CO., LTD.
830 Moo4, Sanambin-BanKlang Road. Kuanlang, Hatyai, Songkhla 90110 THAILAND,
TEL: (66) 7424 0132, 424 0185, 7424 0195 FAX: (66) 7424 0233, 7447 4734
Indications for Use
510(k) Number (if known): K083908
Device Name: Nitrile Examination Gloves Powder-Free (Black Color).
A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.
Mohit
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083908
§ 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.