(57 days)
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
This document describes the acceptance criteria and the study results for the Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove by Ansell Perry.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319 | Meets ASTM D 6319 |
| Physical Properties: | ||
| Tensile Strength, minimum | Meets ASTM D 6319 (14 MPa) | Exceeds ASTM D 6319 (14 MPa) |
| Freedom from holes | Meets ASTM D 6319, Meets ASTM D 5151 | Meets ASTM D 6319, Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass, Meets ASTM D 6124 | Not more than 2 mg residue by mass, Meets ASTM D 6124 |
| Biocompatibility | ||
| Primary Skin Irritation (Rabbits) | Acceptable (Passes) | Passes |
| Guinea Pig Sensitization | Acceptable (Passes) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., for dimensions, tensile strength, freedom from holes, powder-free, or biocompatibility). However, it indicates that the tests were conducted according to established ASTM standards (D 6319, D 5151, D 6124). These standards often prescribe minimum sample sizes for testing.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are "non-clinical tests" conducted to demonstrate conformity with recognized standards like ASTM, which are generally performed in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "ground truth" for medical examination gloves is established by objective, quantifiable measurements against defined performance standards (ASTM standards) and biocompatibility tests, rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set
This information is not applicable. The performance is measured against objective standards, not through subjective adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a medical examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for evaluating the Nitra-Touch™ gloves is defined by:
- Established Industry Standards: ASTM Standard D 6319 (Nitrile Examination Gloves for Medical Application), ASTM D 5151 (Freedom from Holes), and ASTM D 6124 (Powder Residue).
- Biocompatibility Test Pass/Fail Criteria: Standard methods for assessing Primary Skin Irritation and Guinea Pig Sensitization.
- FDA Hole Requirements: The gloves also meet FDA hole requirements.
These ground truths are objective and quantitatively measurable.
8. The sample size for the training set
This information is not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These products are manufactured and then tested for compliance with specifications.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the words "Ansell Perry" in a bold, sans-serif font. The word "Ansell" is in white on a black background, while the word "Perry" is in black on a white background. The two words are placed side by side, creating a contrast between the colors.
Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry
OCT 1 3 1999
1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: Fax: 330-833-6213
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
James R. Chatterton Contact: 8/11/99 Date:
- Nitra-Touch™ Sterile [3] Trade Name: Exam Gloves Common Name: Patient Examination Glove Classification Name:
- Nitra-Touch™ Sterile examination gloves, meet all of the requirements of ASTM Standard D 6319 . [4] Nitrile Examination Gloves for Medical Application.
- Nitra-Touch™ Sterile examination gloves exceed the physical requirements of ASTM standard D [૨] 6319 Nitrile Examination Glove for Medical Application.
- Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that [୧] is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Nitra-Touch™ Sterile examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 6319 |
| Physical PropertiesTensile Strength, minimum | Meets ASTM D 631914 Mpa |
| Freedom from holes | Meets ASTM D 6319Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by massMeets ASTM D 6124 |
Ansell Healthcare Products Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.ansell.com Telephone: 330-833-2811 · Toll Free: 800-321-9752 (USA only) · Fax: 330-833-5991
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Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Biocompatability Primary Skin İrritation in Rabbits Guinea Pig Sensitization
Passes Passes
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [9]
- It is concluded that Nitra-Touch™ Sterile examination gloves are as safe, as effective, and perform [10] as well as or better than the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- This summary will include any other information reasonably deemed necessary by The FDA. [11]
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a human figure, with flowing lines suggesting movement or growth.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Ansell Healthcare Products Inc. 1875 Harsh Avenue S.E. Massillon, Ohio 44646
K992768 Re : Trade Name: Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Gloves Regulatory Class: I Product Code: LZA August 11, 1999 Dated: August 17, 1999 Received:
Dear Mr. Chatterton:
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 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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Chatterton
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (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" (21 CFR 807.97). Other general 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/dsmamain.html".
Sincerely yours,
Susan Runno
t
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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~ ^ Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | Ansell Perry |
|---|---|
| 510(K) Number (if known): | K992768 * |
| Device Name: | Nitra-Touch Patient Examination Glove, Sterile, Nitrile, Green Color, Sterile, Powder Free |
| Indications For Use: |
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
es ... .ption Use r 21 CFR 801.109 OR
Over-The-Counter
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(Optional 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.