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 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.

AI/ML Overview

This document describes the acceptance criteria and performance of the BioExam Powder Free, Sterile Nitrile Examination Glove as presented in its 510(k) summary (K062138).

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (ASTM/ISO Standard or Specific Value)	Reported Device Performance (BioExam Glove)
Overall Length	230mm Minimum (ASTM D3578-99)	280 mm minimum (Sterile version)
Width	S: 80mm ±-10mm, M: 85mm±-10mm, L: 110mm ±-10mm, XL: 120mm±-10mm (ASTM D3578-99)	Small: 80mm ±-10mm, Medium: 90mm±-10mm, Medium-Large: 105mm±-10mm, Large: 111mm±-10mm, X-Large: 120mm±-10mm
Palm Thickness	0.08mm minimum (ASTM D3578-99)	Not explicitly stated for sterile glove, but predicate's "0.09 - 0.13mm minimum" for non-sterile implies meeting/exceeding ASTM minimum.
Finger Thickness	0.08mm minimum (ASTM D3578-99)	Not explicitly stated for sterile glove, but predicate's "0.10 - 0.14mm minimum" for non-sterile implies meeting/exceeding ASTM minimum.
Tensile Strength	14 MPa Before Aging, 14 MPa After Aging (ASTM D3578-99)	Not explicitly stated for sterile glove, but predicate's "16 MPa Before Aging, 14 MPa After Aging" for non-sterile implies meeting/exceeding ASTM minimum.
Ultimate Elongation	700% Before Aging, 500% min After Aging (ASTM D3578-99)	500% minimum before aging, 400% minimum after aging (meeting ASTM D6319 requirements) *Note: This is lower than D3578-99, but meets D6319.
Protein	Zero/Below detection limit using ASTM D 6499	Zero/Below detection limit using ASTM D 6499
Barrier Integrity	Passed ASTM F 1671	Passed ASTM F 1671
Leak Acceptance	AQL 0.65 (ASTM D7161)	AQL 0.65 (ASTM D7161)
Biocompatibility	Passed cytotoxic end-point, ISO Closed Patch Sensitization, and ISO Skin Irritation testing.	Passed all testing (ISO Closed Patch Sensitization and ISO Skin Irritation).
Microbiological Viral Penetration	All acceptance criteria met for negative and positive control samples (negative for viral penetration in negative controls, positive in positive controls).	All acceptance criteria met for both the negative and positive control samples. (Negative control samples negative for viral penetration, positive control samples positive for viral penetration).
Residual Powder Content	N/A (Powder free device)	0.4-1.6mg/glove (demonstrates low residual powder)
Presence of Cornstarch	N/A (Powder free device)	negative

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

The document does not explicitly state the exact sample sizes for each physical and chemical test. However, it indicates compliance with ASTM and ISO standards (e.g., ASTM D3578-99, ASTM D6319, ASTM D6499, ASTM F1671, ASTM D7161, ISO 11137 Part 2, ISO Closed Patch Sensitization, ISO Skin Irritation). These standards typically specify the required sample sizes and testing methodologies.
The data provenance is internal testing performed by the applicant and external testing by NAMSA for biocompatibility. The country of origin of the data is not specified beyond "NAMSA" being a testing laboratory. The studies are prospective in the sense that they are specifically conducted to demonstrate compliance of the device with the standards.

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

This information is not applicable to this type of device submission. The "ground truth" for examination gloves is established by conformance to predefined engineering standards (ASTM, ISO) and regulatory requirements, not through expert consensus on medical images or clinical outcomes. The tests are laboratory-based and objective against specified criteria.

4. Adjudication method for the test set:

Not applicable. See point 3. The data is based on objective laboratory measurements against set thresholds, not on 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:

Not applicable. This device is an examination glove, not an AI-powered diagnostic tool, so 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 an examination glove, not an AI algorithm.

7. The type of ground truth used:

The ground truth consists of internationally recognized and nationally adopted ASTM and ISO standards for physical properties, barrier integrity, biocompatibility, and sterility of medical examination gloves. These standards define the acceptable performance parameters.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device. There is no "training set" in the context of examination glove testing. The manufacturing process is subject to quality control, which involves ongoing testing, but this is distinct from a "training set" for an algorithm.

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

Not applicable. As stated in point 8, there is no training set. The "ground truth" for glove performance is established by the accepted industry and regulatory standards.

Summary

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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, LLC5550 Peachtree Parkway Suite 500Norcross, GA 30092
Contact Person:	Steven Dowdley, Director of Regulatory AffairsTel.: 678-250-7930Fax: 678-250-7986
Device Name:	Proprietary Name:	BioExam Powder Free,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:

	ASTMD3578-99	Powder Free Colored Blue -Nitrile Examination GlovesNonsterile, K000868	Powder Free Colored Blue -NitrileExamination Gloves Sterile
OverallLength:	230mmMinimum	240mmminimum	280 mmminimum
Width:	S: 80mm ±-10mmM: 85mm±-10mmL: 110mm ±-10mmXL: 120mm±-10mm	SmallMediumMedium-LargeLargeX-Large	SmallMediumMedium-LargeLargeX-Large	80mm ±-10mm90mm±-10mm105mm±-10mm111mm±-10mm120mm±-10mm
PalmThickness:	0.08mm minimum	0.09 - 0.13mm minimum
FingerThickness:	0.08mm minimum	0.10 - 0.14mm minimum
TensileStrength:	14 MPa Before14 MPa After Aging	16 MPa Before Aging14 MPa After Aging
UltimateElongation:	700% Before Aging500% min AfterAging	700% Before Aging500% minimum After Aging	500% minimum before aging400% minimum after aging(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)
LeakAcceptance	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

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.