← Product Code [LZA](/productcode/LZA) · K062138

# POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE (K062138)

_Molnlycke Health Care, Inc. · LZA · Oct 5, 2006 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K062138

## Device Facts

- **Applicant:** Molnlycke Health Care, Inc.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Oct 5, 2006
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

## Device Story

Sterile, powder-free, blue nitrile examination glove; intended for use by healthcare personnel to provide a barrier against contamination between the wearer and the patient. Device functions as a physical barrier; manufactured from nitrile material. Used in clinical or healthcare settings. Provides protection against blood-borne pathogens; tested for viral penetration. Benefits include reduced risk of cross-contamination during patient examinations.

## Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO Closed Patch Sensitization and Skin Irritation), viral penetration testing (ASTM F1671), physical property testing (tensile strength, elongation per ASTM D3578-99/D6319), and residual powder content analysis.

## Technological Characteristics

Material: Nitrile. Form: Sterile, powder-free, blue examination glove. Standards: ASTM D3578-99, ASTM D6124-97, ASTM D6319, ASTM F1671, ASTM D7161, ISO 11137 Part 2. Physical properties: AQL 0.65 for integrity/leakage. Biocompatibility: Passed ISO skin sensitization and irritation tests. Protein content: Below detection limit (ASTM D6499).

## Regulatory 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.

## Predicate Devices

- Powder Free Nitrile Exam Glove ([K000868](/device/K000868.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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Ko62138

Image /page/0/Picture/1 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five circles on the left side, resembling a paw print or a flower. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in two lines. The text is in a simple, sans-serif font.

MoInlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)

OCT - 5 2006

# ATTACHMENT VIIII - 510(k) SUMMARY

| Applicant:         | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway Suite 500<br>Norcross, GA 30092   |                                                           |  |
|--------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------|--|
| Contact Person:    | Steven Dowdley, Director of Regulatory Affairs<br>Tel.: 678-250-7930<br>Fax: 678-250-7986 |                                                           |  |
| Device Name:       | Proprietary Name:                                                                         | BioExam Powder Free,<br>Sterile Nitrile Examination Glove |  |
|                    | Common Name:                                                                              | Exam Glove (CFR 880.6250)                                 |  |
|                    | Classification:                                                                           | Class I                                                   |  |
| Predicate Device : |                                                                                           | Powder Free Nitrile Exam Glove (K000868)                  |  |

### Device Description:

Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.

#### Intended Use of the Device:

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

### Technological Characteristics of the Device:

|                         | ASTM<br>D3578-99                                                      | Powder Free Colored Blue -<br>Nitrile Examination Gloves<br>Nonsterile, K000868 | Powder Free Colored Blue -Nitrile<br>Examination Gloves Sterile                            |                                                                        |
|-------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Overall<br>Length:      | 230mm<br>Minimum                                                      | 240mm<br>minimum                                                                | 280 mm<br>minimum                                                                          |                                                                        |
| Width:                  | S: 80mm ±-10mm<br>M: 85mm±-10mm<br>L: 110mm ±-10mm<br>XL: 120mm±-10mm | Small<br>Medium<br>Medium-Large<br>Large<br>X-Large                             | Small<br>Medium<br>Medium-Large<br>Large<br>X-Large                                        | 80mm ±-10mm<br>90mm±-10mm<br>105mm±-10mm<br>111mm±-10mm<br>120mm±-10mm |
| Palm<br>Thickness:      | 0.08mm minimum                                                        | 0.09 - 0.13mm minimum                                                           |                                                                                            |                                                                        |
| Finger<br>Thickness:    | 0.08mm minimum                                                        | 0.10 - 0.14mm minimum                                                           |                                                                                            |                                                                        |
| Tensile<br>Strength:    | 14 MPa Before<br>14 MPa After Aging                                   | 16 MPa Before Aging<br>14 MPa After Aging                                       |                                                                                            |                                                                        |
| Ultimate<br>Elongation: | 700% Before Aging<br>500% min After<br>Aging                          | 700% Before Aging<br>500% minimum After Aging                                   | 500% minimum before aging<br>400% minimum after aging<br>(meeting ASTM D6319 requirements) |                                                                        |

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Image /page/1/Picture/0 description: The image shows a logo with a cluster of circles on the left and the words "MOLNLYCKE HEALTHCARE" on the right. The circles are arranged in a way that resembles a flower or a cell structure. The text is stacked vertically, with "MOLNLYCKE" on top of "HEALTHCARE". The logo appears to be for a healthcare company.

Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)

| Protein            | Zero/Below detection limit using ASTM D 6499 |
|--------------------|----------------------------------------------|
| Barrier            | Passed ASTM F 1671                           |
| Integrity          | AQL 0.65 (ASTM D7161)                        |
| Leak<br>Acceptance | AQL 0.65 (ASTM D7161)                        |

#### Biocompatibility:

In vitro biocompatibility testing was completed by NAMSA to determine the cytotoxic end-point of the test device extract. The results showed that the sterile gloves passed all testing (ISO Closed Patch Sensitization and ISO Skin Irritation).

Microbiological viral penetration testing of protective clothing material intended to protect against blood borne pathogen hazards was also conducted. All acceptance criteria was met for both the negative and positive control samples. The negative control samples were negative for viral penetration, and the positive control samples were positive for viral penetration.

#### Comparison to the Predicate:

The BioExam Sterile Powder Free Nitrile Examination Glove is substantially equivalent in safety, design and indication for use to the powder free nitrile examination gloves previously cleared under K000868.

#### Total Residual Powder Content & Presence of Cornstarch:

Residual Powder Content - 0.4-1.6mg/glove Presence of Cornstarch - negative

#### Clinical Data:

Clinical data is not needed required for gloves.

#### Conclusion:

The data provided in this 510(k) summary concludes BioExam Powder Free Sterile Nitrile Exam Glove substantially equivalent to the previously clear device under K000868.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Dowdley Director of Regulatory Affairs Molnlycke Healthcare, Incorporated 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

OCT - 5 2006

Re: K062138

Trade/Device Name: Sterile Powder Free, Blue Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 22, 2006 Received: September 25, 2006

Dear Mr. Dowdley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prolibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class 111 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Dowdley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good mianufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Cluz

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/1 description: The image shows a logo with a cluster of circles on the left and the text "MÖLNLYCKE HEALTHCARE" on the right. The circles are arranged in a triangular pattern, with some overlapping. The text is in a simple, sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTHCARE" on the bottom line.

Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)

3,0 Indications for Use Statement:

### INDICATION FOR USE

Applicant:

Molnlycke Heath Care US, LLC

K062138 510(k) Number:

Sterile Powder Free, Blue Nitrile Examination Glove Device Name:

Indication for Use:

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBOED) Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use   | Or Over-The-Counter X |
|--------------------|-----------------------|
| Per 21 CFR 801.109 |                       |

Shule A. Maughy, ho 11/3/06

n of Anesthesiology, General Hospical, Control. Dental Devices

Number 462/38

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**Source:** [https://fda-staging.innolitics.com/device/K062138](https://fda-staging.innolitics.com/device/K062138)

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