(134 days)
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
This document is a 510(k) Pre-Market Notification for the Nitra-Touch™ examination gloves. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | ASTM D 3578 (except for ultimate elongation) | Meets ASTM D 3578 (except for ultimate elongation). Explicitly states: "Original Ultimate Elongation 500% minimum" and "Aged Ultimate Elongation 400% minimum" - these values are variations from ASTM D 3578 but are presented as met specifications under Attachment II. |
| Freedom from holes | ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Described test in Attachment V (Not more than 2 mg residue by mass) | Meets described test in Attachment V |
| Tensile Strength | Vinyl = 10.5 MPa (for comparison) | Nitra-Touch™ = 17.1 MPa (60% higher than vinyl) |
| Puncture Resistance | ASTM D 120-87 (for comparison) - specifically mentions "Vinyl (Synthetic) = 184 lbf/in" and "Blue Nitrile = 929 lbf/in" for context. | Nitra-Touch™ = 1625 lbf/in (eight times greater than vinyl and nearly twice that of competitive nitrile gloves) |
| Glutaraldehyde Resistance | ASTM F739-91 (Permeation Rate = < 0.013 Fg/cm² min, Breakthrough Time = >480 minutes) | Permeation Rate = < 0.013 Fg/cm² min; Breakthrough Time = >480 minutes. The document states "Nitrile film provides excellent chemical resistance to glutaraldehyde" and references ASTM T F739-91, with "Source: TRI/Environmental, Inc." for the permeation data. |
| Biocompatibility (Primary Skin Irritation) | Not explicitly stated as a standard, but implies a pass/fail criteria from a common test. | Passes (in Rabbits) |
| Biocompatibility (Guinea Pig Sensitization) | Not explicitly stated as a standard, but implies a pass/fail criteria from a common test. | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" and rather references compliance with existing ASTM standards and internal tests. Information regarding sample sizes for each specific test (e.g., freedom from holes, tensile strength, puncture resistance, biocompatibility) is not provided. The data provenance is implied to be from internal testing conducted by Ansell Edmont Industrial, Inc. and potentially third-party labs like TRI/Environmental, Inc. for the glutaraldehyde resistance. The data is presented as retrospective as it's being submitted for current product clearance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for the performance characteristics of medical examination gloves is established by the specified ASTM (American Society for Testing and Materials) standards and FDA requirements. The tests are physical and chemical measurements against these quantitative standards, not subjective assessments requiring expert consensus for ground truth.
4. Adjudication method for the test set
This is not applicable. As stated above, the performance is measured against established quantitative standards, not through subjective interpretation requiring 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
There is no MRMC comparative effectiveness study mentioned or implied. This device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating the Nitra-Touch™ examination gloves is based on established industry standards (ASTM) and regulatory requirements (FDA) for medical examination gloves. These standards define specific physical and chemical properties (e.g., dimensions, strength, freedom from holes, biocompatibility) with quantitative pass/fail criteria.
8. The sample size for the training set
This is not applicable. This is a submission for a physical medical device (gloves) and does not involve a "training set" in the context of machine learning or AI models. The manufacturing processes and quality control would involve statistical sampling, but this is distinct from a "training set" for an algorithm.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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Ansell Edmont Industrial Inc.
Costincton OH 43812
Technology Center Telephone: (740) 623-3593 Technology Center Fax: (740) 623-3515
i
Nitra-Touch™ Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: 740-622-4311 Fax: 740-623-3515
Checklist Section 21.0
OCT 2 9 1998
- 510 (k) Summary [1]
- [2] Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812
Telephone: 740-622-4311 740-623-3515 Fax:
Contact: Mike W. Hagans Telephone: 740-623-3595 740-623-3515 Fax:
June 12, 1998
| [3] | Trade Name: | Nitra-Touch™ |
|---|---|---|
| Common Name: | Exam Gloves | |
| Classification Name: | Patient Examination Glove |
- Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with [4] the following variation.
- Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 [ર] Rubber Examination Gloves except for the ultimate elongation percentage before and after aging.
- [6] Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
- [7] Nitra-Touch™ examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 |
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Nitra-Touch™ Ansell Edmont Industrial. Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: 614-622-4311 Fax: 614-623-3515
Except Ultimate Elongation meets specifications described under Attachment II
Freedom from holes Meets ASTM D 5151
Powder-Free Meets described test in Attachment V Original Ultimate Elongation 500% minimum Aged Ultimate Elongation 400% minimum
Meets ASTM D 3578
ASTM D 5250
ASTM D 3578
Not more than 2 mg residue by mass.
Tensile Strength MPa Tensile Strength 60% higher than vinyl (synthetic) examination gloves Vinyl = 10.5 Nitra-Touch™ = 17.1
Puncture lbf/in Puncture resistance of Nitra-TouchTM is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves
Glutaraldehyde Resistance Nitrile film provides excellent chemical resistance to glutaraldehyde.
Permeation Rate = < 0.013 Fg/cm2 min Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
ASTM D 120-87 Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184
ASTM T F739-91 Source: TRI/Environmental, Inc. Breakthrough Time = >480
Passes Passes
- [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
- ld] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and [10] perform as well as 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 [1]] FDA.
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OCT 2 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mike W. Hagans Ansell Edmont Industrial, Incorporated 1300 Walnut Street Coshocton, Ohio 43812
Re : K982131 Nitra-Touch™ Powder-Free Nitrile Medical Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: September 9, 1998 Received: September 21, 1998
Dear Mr. Hagans:
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 regulations 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 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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Hagans
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,
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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3.0 Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | Ansell Edmont Industrial, Inc. |
|---|---|
| 510(K) Number (if known): | K982131 * |
NITRA TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
| Device Name: | Patient Examination Glove |
|---|---|
| -------------- | --------------------------- |
Indications For Use:
3
r 21 CFR 801.109
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K982131 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter | X |
|---|---|---|---|
| ------------------ | ---- | ------------------ | --- |
§ 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.