NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

K965095 · Ansell Edmont Industrial, Inc. · LZA · Apr 22, 1997 · General Hospital

Device Facts

• Record ID: K965095
• Device Name: NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
• Applicant: Ansell Edmont Industrial, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Nitra-Touch™ is a disposable nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device provides barrier protection; features high puncture resistance (8x greater than vinyl, 2x greater than competitive nitrile) and chemical resistance to glutaraldehyde. Used in clinical settings; operated by healthcare professionals. Output is physical barrier protection; affects clinical decision-making by ensuring sterile/clean environment during patient examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D 3578 (dimensions, physical properties), ASTM D 5151 (freedom from holes), ASTM F739-91 (glutaraldehyde resistance), and biocompatibility studies (primary skin irritation in rabbits, guinea pig sensitization).

Technological Characteristics

Nitrile film material. Dimensions and physical properties meet ASTM D 3578 (except ultimate elongation: 500% original, 400% aged). Puncture resistance 1625 lbf/in (ASTM D 120-87). Tensile strength 17.1 MPa. Powder-free (<2 mg residue). Biocompatible.

Indications for Use

Indicated for use as a patient examination glove to prevent contamination between patient and examiner.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}

Ansell Edmont Industrial

Ansell Edmont Industrial Inc.

400 Northridge Rd.
Suite 800
Atlanta, Georgia 30350

Telephone: [phone]

FAX: [phone]

K965055

Nitra-Touch™

Checklist

Section 21.0

[1] 510 (k) Summary
[2] Ansell Edmont Industrial, Inc.
400 Northridge Road, Suite 800
Atlanta, GA 30350

APR 22 1997

Telephone: [phone]
Fax: [phone]

Contact: Mike W. Hagans
Telephone: [phone]
Fax: [phone]

December 12, 1996

[3] Trade Name: Nitra-Touch™
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.
[5] 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 meets specifications described under Attachment II | Original Ultimate Elongation 500% minimum
Aged Ultimate Elongation 400% minimum |

Revised 2/21/97

{1}

Ansell Edmont
Industrial
Ansell Edmont Industrial Inc.
400 Northridge Rd.
Suite 800
Atlanta, Georgia 30350
Telephone: [phone]
FAX: [phone]

Nitra-Touch™

Freedom from holes
Meets ASTM D 3578
Meets ASTM D 5151

Powder-Free
Meets described test in Attachment V
Not more than 2 mg residue by mass.

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.

Tensile Strength MPa
ASTM D 5250
ASTM D 3578
Vinyl = 10.5
Nitra-Touch™ = 17.1

Puncture lbf/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 = &gt;480
Permeation Rate = &lt;0.013 µg/cm²* min

Biocompatibility
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.
[9] 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.

[11] This summary will include any other information reasonably deemed necessary by The FDA.

Revised 2/21/97