BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT by MOLNLYCKE HEALTHCARE, US LLC

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.

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.

AI/ML Overview

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Biogel Orthopedic Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical effectiveness with extensive studies. As such, many of the requested elements (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) are not relevant or typically included in such filings for this class of device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	Meets ASTM D3577	Meets ASTM D3577
Physical Properties	Meets ASTM D3577	Meets ASTM D3577
Freedom from Holes	Meets ASTM D3577	Meets ASTM D3577
Biocompatibility	Meets ISO 10993-1	Meets ISO 10993-1
LAL Test (Endotoxin)	< 0.25 EU/ml	< 0.25 EU/ml
Total Water Extractable Protein	≤ 50 micrograms/gram	≤ 50 micrograms/gram

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. For this type of device and regulatory pathway, testing typically involves validating against specified ASTM and ISO standards. These standards define the sampling plans and testing methodologies.
Data Provenance: Not specified, but generally refers to in-house laboratory testing following established international standards (ASTM, ISO).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for performance characteristics of surgical gloves is established by objective, standardized laboratory tests according to ASTM and ISO specifications, not by expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. Performance is measured objectively through lab tests against predefined specifications, not through adjudication of expert opinions.

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:

Not applicable. This device is a surgical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is a physical product (surgical glove), not an algorithm.

7. The type of ground truth used:

The "ground truth" is defined by the objective thresholds and methodologies specified in the ASTM D3577 standard for surgical gloves, ISO 10993-1 for biocompatibility, and LAL test standards for endotoxin levels, along with the specified protein content limit. These are laboratory-derived, validated standards.

8. The sample size for the training set:

Not applicable. This device is manufactured to meet specifications, not "trained" like a machine learning model.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary of Study (Performance Data):

The performance data presented in the 510(k) summary are derived from testing the Biogel Orthopedic Surgical Glove against established industry standards. The manufacturer states that the device was tested to meet the requirements of:

ASTM D3577: This standard specifies the requirements for rubber surgical gloves, covering aspects like dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
ISO 10993-1: This standard covers biological evaluation of medical devices, ensuring biocompatibility.
LAL Test: This test measures endotoxin levels. The device met the requirement of <0.25 EU/ml (non-pyrogenic claim).
Protein Content Claim: The glove contains 50 micrograms or less of total water extractable protein per gram, meeting its specific labeling claim.

The submission concludes that "No clinical data was required" because the device demonstrated substantial equivalence to predicate devices (K980516 and K060030) based on these technological characteristics and performance data against recognized standards.

Summary

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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.: 678-250-7930 Fax: 678-250-7979 3. 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.
1. 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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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 (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 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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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:

(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

າການປະກວດນາງປະຊາດປົກການປີ ການປີ ວອກຕອງໄທ នៅជន១។ នោះទេមាន (190-upis noisiviO)

Shula A. Murphy, MD

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
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.(b)
Classification. Class I (general controls).