A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Description

This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Safeskin Hypoallergenic Powder-Free Nitrile Examination Gloves, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Physical Properties
ASTM D3578-91	Compliance with dimensional measurement requirements (thickness, etc.), except for pre-aged ultimate elongation.	Applicant glove and K932404 comply.
ASTM D5250-92	Far exceed requirements for synthetic (non-natural latex) examination gloves.	Applicant glove far exceeds requirements.
FDA Water Leak Test	No leaks with 1,000 mL of water within a two-minute period. Sampling per Mil Std. 105E or increased tightness.	Applicant glove and K932404 meet this requirement.
Powder-Free Assessment	(No specific FDA/ASTM standards set, but comparison to predicate device is key)
Residue Weight	≤ 2 mg (internal benchmark, compared to predicate)	Same as predicate (K932404), very low particulate levels.
Iodine Assay (Cornstarch)	< 5 mg (internal benchmark, compared to predicate)	Same as predicate (K932404), very low cornstarch levels.
Biocompatibility
Primary Dermal Irritation	Pass (no significant irritancy potential based on Consumer Product Safety Commission, Title 16, Chapter II, Part 1500)	Applicant glove: Pass (no significant irritancy potential).
Dermal Sensitization (Buehler)	Pass (no significant sensitization potential based on ASTM Standard F 720-81 (Reapproved in 1986))	Applicant glove: Pass (no significant sensitization potential).
200 Person Modified Draize Test	Pass (no primary or cumulative irritation and/or sensitization potential as per DSMA Regulatory Requirements for Medical Gloves, May 1993)	Applicant glove: Pass (performed to obtain Hypoallergenic claim).

2. Sample Size Used for the Test Set and Data Provenance

FDA Water Leak Test: Sampling performed utilizing Mil Std. 105E or an increased sampling tightness when deemed appropriate. (Specific number not provided, but refers to a standard).
Powder-Free Assessment: Not explicitly stated, implied to be samples of the applicant device.
Primary Dermal Irritation: Shaved intact and abraded skin on the backs of albino rabbits. (Specific number of rabbits not provided).
Dermal Sensitization (Buehler) Study: Fifteen young adult Hartley Guinea Pigs (male) per extract.
200 Person Modified Draize Test: 200 persons (human subjects).
Data Provenance: Not explicitly stated, but the studies were conducted to comply with US regulations (FDA, ASTM, Consumer Product Safety Commission), suggesting US-based or compliant testing. The studies appear to be prospective, specifically performed for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies.
Instead, "ground truth" is established by the standardized methods themselves (e.g., visual inspection for leaks, weight measurement for powder, observation of skin reactions in animal/human models by trained personnel). The document does not specify the number or qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable as the tests described are objective measurements or standardized biological response assessments, not subjective interpretations 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

No, this is a regulatory submission for medical gloves, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study involving AI is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is a physical medical glove, not a software algorithm.

7. The Type of Ground Truth Used

Objective Measurements: For physical properties (thickness, water leak test, residue weight, iodine assay), the "ground truth" is based on the results of standardized measurement techniques.
Biological Response: For biocompatibility tests (dermal irritation, sensitization), the "ground truth" is based on observed biological reactions (e.g., presence or absence of irritation/sensitization) in animal models or human subjects, assessed against established scoring criteria (e.g., Draize evaluation).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device. The concept of a "training set" for physical product testing is not relevant in this context. The testing described focuses on verifying product specifications and safety against established standards.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI device, there is no "training set" or corresponding ground truth to establish in that manner.

Summary

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K962139

DEC 1 9 1996

Safeskin Corporation Submitted: May 28, 1996 Contact: Michelle Molloy 12671 High Bluff Drive San Diego, California 92130 Phone: (619) 784-8111 Fax: (619) 350-2380

Attachment 8 510(k) Summary of Safety and Effectiveness

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Image /page/1/Picture/0 description: The image shows the logo for SAFESKIN. The logo consists of a circle with two curved lines inside, resembling an "S". Below the circle, the word "SAFESKIN" is written in bold, sans-serif font. There is a trademark symbol to the right of the word SAFESKIN.

Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130 Tel: (800) 462-9993 (619) 784-8111 Fax: (619) 350-2380

Hypoallergenic Powder-Free Nitrile Examination Gloves

510 (K) SUMMARY of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. [807.92(c)] Separate Document
  **

2. [807.92(a)] Applicant:	Safeskin Corporation12671 High Bluff DriveSan Diego, California 92130Phone: (619) 784-8111Fax: (619) 350-2380
Contact:	Michelle MolloySafeskin Corporation12671 High Bluff DriveSan Diego, California 92130Phone: (619) 784-8111Fax: (619) 350-2380
3. [CFR 880.6250]	Date Summary Prepared: May 28, 1996Name of Device:Proprietary Name: SafeskinCommon Name: Nitrile exam glovesClassification: Patient examination glove (per 21CFR 880.6250)
4. [807.92 (a)(3)]	Equivalence: The legally marketed device to which equivalence is claimed is K932404 (Safeskin) a Class 1 Nitrile patient examination glove 80 EMC

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5. [807.92(a)(4)]

Description:

	Same	Different
Formulation	✓
Processing	✓
Powder-Free	✓
Non-Sterile	✓
Biocompatibility	✓
Physical Testing	✓
Hypoallergenic		✓
Colorant		✓

Similarity and Differences Comparison Between Safeskin's K932404 and This New Submission

Intended Use: 6. [807.92(a)(5)] A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. 7. [807.92(a)(6)] Technological Characteristics of applicant device compared to predicate device; non-clinical performance data: Both gloves comply with ASTM 3578-91 Standard and the FDA Water
Leak Test.
Gloves comply with ASTM D3578-91 and FDA. 1,000 mL Water Leak requirement. A.
The powder-free assessment which follows is based upon the procedure: B.

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Tests for Particulates by Weight and lodine Color as described on pg. 5.54 in Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA, May 1993.

B. Powder-free Assessment		COMPARISON
		K932404	Applicant Device
Residue weight	$\leq$ 2 mg	same glove	same glove
Results of iodine assay (cornstarch)	< 5 mg	same glove	same glove

C. BiocompatibilityAs recommended by the TripartiteGuidance on Biocompatibility ofMedical Devices		COMPARISON
		K932404	Applicant Device
		Pass/Fail
•	Primary Dermal IrritationConsumer Product SafetyCommission, Title 16, Chapter II,Part 1500	Pass	Pass
•	Dermal Sensitization (Buehler)StudyASTM Standard F 720-81(Reapproved in 1986)	Pass	Pass
•	200 Person Modified Draize TestDSMA Regulatory Requirementsfor Medical Gloves, May 1993.	Not tested	Pass

Non-clinical performance data: 8. [807.92(a)(c)]

A summary of results of non-clinical performance evaluations is presented above. A brief description of these tests follows:

A: Dimensional and Physical Properties.

ASTM D3578-91 specifies the dimensional measurement requirements including thickness to which the Applicant and K932404 gloves comply, unless otherwise noted.

1,000 mL FDA Water Leak Test consists of attaching a glove over the end of a plastic cylinder and dispensing 1,000 mL of water into the glove. Leaks within a two-minute period are recorded as failures. Testing is performed according to 21CFR 800.20 (b)(1). Sampling is performed utilizing Mil Std. 105E or an increased sampling tightness when deemed appropriate. Applicant glove and K932404 meet this FDA requirement.

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B: The powder-free test method is an assay, described as recommendations in the Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA May, 1993. A water extract of the gloves is filtered, dried and the residue weighed to determine the total particulate removed from the glove. K932404 demonstrate Applicant glove and verv low particulate/cornstarch levels; however, no standards have been set by the FDA or the ASTM.

C: Biocompatibility.

Primary Dermal Irritation. The testing is performed according to the regulations of the Consumer Product Safety Commission, Title 16, Chapter II, Part 1500. The purpose of the study is to determine the dermal irritation potential of the glove to the shaved intact and abraded skin on the backs of albino rabbits. Appropriate controls were conducted. Applicant glove showed no significant irritancy potential.

Dermal Sensitization (Buehler) Study. This study is performed on fifteen young adult Hartley Guinea Pigs (male) per extract to determine the sensitization potential of the gloves. Safeskin Powder-Free Nitrile Exam Gloves were tested with Dinitrochlorobenzene (DCNB) used for a positive control substance. A one inch square patch of test material was applied to clipped areas of the test animals, once weekly for three weeks, six hours per exposure. Erythema and edema were scored according to Draize evaluation. The Challenge phase was conducted two weeks after the last administration of induction dose in the same manner as previously described. Appropriate controls were conducted. Applicant glove showed no significant sensitization potential.

9. [807.92(b)(2)] Clinical Performance Data:

The 200 person Modified Draize Test was performed on the applicant glove to comply with FDA requirements for obtaining the Hypoallergenic claim. This test was conducted to determine by epidermal contact the primary or cumulative irritation and/or sensitization potential of the test material. Test site was the upper back between the scapulae. Test sample portions of the glove were attached to the back. This procedure was followed three times per week for a total of ten applications. Observations and scoring were made at each test period. Following a two-week rest period, two consecutive challenge patches of the test material were applied to a different site on the scapular back under occlusive patches.

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10. [807.92 (b)(3)]	Conclusions drawn from the non-clinical and clinical tests in 7, 8,and 9 above:The applicant glove meets or exceeds ASTM standards, FDA pinholerequirements and labeling claims as demonstrated in 7, 8, and 9 above.
11. [807.92 (d)]	Other information deemed necessary by the FDA.

[807.92 (d)] No other information has been requested at this time.

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Regulation Number and Section

§ 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.