(124 days)
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.
Nitra-Touch™ examination gloves
This document describes the acceptance criteria and performance of Nitra-Touch™ examination gloves, specifically focusing on their compliance with ASTM standards and other relevant criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578, Except Ultimate Elongation: Original 500% minimum, Aged 400% minimum | Meets ASTM D 3578, Except Ultimate Elongation meets specifications described under Attachment II (Specific percentages for Nitra-Touch™'s performance are not provided in the text beyond stating it "meets specifications described under Attachment II" - further detail would be in the attachment). |
| Freedom from holes | Meets described test in Attachment V (and implicitly, FDA hole requirements) | Powder-Free: Meets described test in Attachment V; Meets ASTM D 5151 |
| Residual Powder | Not more than 2 mg residue by mass (for powder-free gloves) | Not more than 2 mg residue by mass |
| Tensile Strength | Measured against ASTM D 5250 and ASTM D 3578 for vinyl (10.5 MPa) | 60% higher than vinyl (synthetic) examination gloves; Nitra-Touch™ = 17.1 MPa (ASTM D 5250) |
| Puncture Resistance | Measured against ASTM D 120-87 for Blue Nitrile (929 lbf/in) and Vinyl (184 lbf/in) | Eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves; Nitra-Touch™ = 1625 lbf/in |
| Glutaraldehyde Resistance | ASTM T F739-91 (Breakthrough Time and Permeation Rate) | Breakthrough Time = >480 minutes; Permeation Rate = < 0.013 ug/cm² min |
| Biocompatibility - Primary Skin Irritation | (Standard implicit for medical devices intended for skin contact) | Passes (in Rabbits) |
| Biocompatibility - Guinea Pig Sensitization | (Standard implicit for medical devices intended for skin contact) | Passes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for holes, tensile strength, etc.). The mention of "non clinical tests" suggests these are laboratory-based evaluations.
The data provenance is not explicitly stated in terms of country of origin. The testing for Glutaraldehyde Resistance was performed by "TRI/Environmental, Inc.", which is likely a US-based laboratory, but this is not definitively stated as the origin of all data. The study appears to be prospective in nature, as new glove samples would be manufactured and tested against predefined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes the performance of a physical product (examination gloves) against established laboratory standards (ASTM standards and other performance metrics) rather than the interpretation of medical images or data requiring expert consensus or ground truth in the context of AI or diagnostics. The "ground truth" here is the physical measurement and chemical testing results according to the specified test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI evaluations where multiple human readers review data and discrepancies need to be resolved. For laboratory testing of physical products, the results are derived directly from the test methodology, and repeatability/reproducibility are typically addressed within the standard itself.
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 section is not applicable. This document describes the performance of a medical device (examination gloves) through laboratory testing, not an AI system. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document describes the performance of a medical device (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Nitra-Touch™ examination gloves is based on:
- Established ASTM Standards and Test Methods: These standards define specific procedures and criteria for evaluating properties like dimensions, physical properties (tensile strength, elongation), freedom from holes, and tensile strength (ASTM D 3578, ASTM D 5250, ASTM D 5151, ASTM D 120-87, ASTM T F739-91).
- Laboratory Measurements and Chemical Analyses: The performance metrics (e.g., MPa for tensile strength, lbf/in for puncture resistance, breakthrough time for chemical resistance, mg residue by mass) are direct results of these standardized tests.
- Biocompatibility Testing Protocols: "Passes" for Primary Skin Irritation and Guinea Pig Sensitization indicate adherence to established biological safety testing protocols for medical devices.
8. The sample size for the training set
This section is not applicable. There is no "training set" in the context of evaluating the performance of physical examination gloves. This concept applies to machine learning models, not physical product testing.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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nta. Georgia 30350
Telephone:
(770) 641-1900
Ansell Edmont Industrial Inc.
FAX: (770) 641-1988
K965055 Nitra-Touch
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Edmont Industrial, Inc. 400 Northridge Road. Suite 800 Atlanta, GA 30350
Telephone: 770-641-1900 Fax: 770-641-1988
Contact: Mike W. Hagans 614-623-3595 Telephone: Fax: 614-623-3515
December 12, 1996
- [3] Nitra-Touch™ Trade Name: Common Name: Exam Gloves Classification Name: Patient Examination Glove
- [4] Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with the following variation.
- (ર) Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 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.
- [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 |
| Except Ultimate Elongation meetsspecifications described underAttachment II | Original Ultimate Elongation 500% minimumAged Ultimate Elongation 400% minimum |
Revised 2/21/97
0
APR 22 1997
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Ansell Edmont Industrial Inc.
400 Northridge Rd. Suite 800 Atlanta, Georgia 30350 Telephone: (770) 641-1900 FAX: (770) 641-1988
Nitra-Touch™
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Freedom from holes
Powder-Free Meets described test in Attachment V
Tensile Strength 60% higher than vinyl (synthetic) examination gloves
Puncture resistance of Nitra-Touch™ is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves
Nitrile film provides excellent chemical resistance to glutaraldehyde.
Meets ASTM D 3578 Meets ASTM D 5151
Not more than 2 mg residue by mass.
Tensile Strength MPa ASTM D 5250 ASTM D 3578 Vinyl = 10.5 Nitra-Touch™ = 17.1
Puncture Ibf/in ASTM D 120-87 Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184
Glutaraldehyde Resistance ASTM T F739-91 Source: TRI/Environmental, Inc. Breakthrough Time = >480 Permeation Rate = < 0.013 ug/cm2" min
Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
ਂ
Passes Passes
- [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
- િ Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- [10] It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and 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.
- [1] This summary will include any other information reasonably deemed necessary by The FDA.
Revised 2/21/97
§ 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.