BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT

K071465 · Molnlycke Health Care Us, LLC · KGO · Sep 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071465
• Device Name: BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Biogel Orthodaepic Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Device Story

Biogel Orthopedic Surgical Glove is a sterile, powder-free, polymer-coated natural rubber latex glove. Designed for use in surgical settings by healthcare professionals; provides a protective barrier against infectious materials and contaminants. Device features low protein content (≤50 micrograms/gram) and non-pyrogenic properties. No complex electronics, software, or algorithms involved.

Clinical Evidence

No clinical data was required; substantial equivalence is based on bench testing and adherence to recognized standards.

Technological Characteristics

Natural rubber latex surgical glove; polymer-coated; powder-free. Meets ASTM D3577 for dimensions, physical properties, and freedom from holes. Biocompatibility per ISO 10993-1. Non-pyrogenic (LAL test <0.25 EU/ml). Protein content ≤50 micrograms/gram.

Indications for Use

Indicated for use as a protective barrier on the hands of healthcare personnel in surgical settings to prevent transmission of infectious materials and contaminants.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Biogel Orthodaepic Surgical Glove (K980516)
• Eclipse, Non-pyrogenic, Latex, Powder-free, Glove (K060030)

Submission Summary (Full Text)

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## K041465

- 510(k) SUMMARY 1. Applicant: Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 SEP 1 1 2007 Norcross, GA 30092 2. Contact Person: Steven Dowdley, RAC Director of Regulatory Affairs Tel.: [phone] Fax: [phone]. Device Name: Biogel Orthodeapic Surgical Glove with non-pyrogen statement Common Name: Classification: Surgical Glove (CFR 878.4461) Class I র্ব Predicate Device : K980516 - Biogel Orthodaepic Surgical Glove K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove 5. Device Description: The Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram. 6. Intended Use of the Device: The Biogel Orthodaepic Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. 7. Technological Characteristics of the The Biogel Orthodaepic Surgical Glove characteristics are Device: summarized below as compared to ASTM requirements and to the predicate devices. Characteristic Standard Dimensions Meets ASTM D3577 Physical Properties Meets ASTM D3577 Freedom from Holes Meets ASTM D3577 Biocompatibility Meets ISO 10993-1 LALTest - final endotoxin <0.25EU/ml concentration 8. Performance Data The performance data are summarized above. 9. Clinical Data No clinical data was required.
- 10. Conclusion:

The Biogel Orthodaepic Surgical Glove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and professional.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2007

Mr. Steven Dowdley, RAC Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K071465

Trade/Device Name: Biogel Powder-Free Orthopedic Latex Surgical Glove, with Protein Content Labeling Claim (50 micrograms or less) & with Non-Pyrogenic Claim

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 22, 2007 Received: August 27, 2007

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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (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 manufacturing 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of circular shapes on the left, resembling a molecular structure or a group of cells. To the right of the shapes, the text "MOLNLYCKE HEALTH CARE" is displayed in a simple, sans-serif font. The text is stacked in two lines, with "MOLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

## 3.0 Indications for Use Statement:

Applicant: Molnlycke Heath Care US, LLC

510(k) Number: K071465

Device Name: Biogel Powder-Free Orthopedic Latex Surgical Glove, with Protein Content Labeling Claim (50micrograms or less) & with Non-Pyrogenic Claim

## Indication for Use:

The Biogel Orthopedic Surgeon's Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

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

Prescription Use

Or Over-The-Counter __________________________________________________________________________________________________________________________________________________________

sinə aid bitki növü. İstinadlar Ş

Per 21 CFR 801.109

K07/445

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Shula A. Murphy, MD

.