A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Patient Examination glove - Disposable- Single use only - Non-sterile - The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the AmerCare C2 Powder Free Polyethylene Examination Glove meets those criteria.

Table of Acceptance Criteria and Reported Device Performance:

Physical Dimensions	Acceptance Criteria (FDA Recognized consensus standard ASTM D 5250-06)	Reported Device Performance (C2 Powder Free Polyethylene Examination Gloves)
Overall Length	230 mm minimum	$255 \pm 5$ mm
Width (for large glove)	$105 \pm 5$ mm	$105 \pm 5$ mm
Palm thickness	0.08mm minimum	0.08mm minimum
Finger thickness	0.05mm minimum	0.05mm minimum
Tensile Strength
Before Aging	11 MPa minimum	11 MPa minimum
After Aging	11 MPa minimum	11 MPa minimum
Ultimate Elongation
Before Aging	300% minimum	300% minimum
After Aging	300% minimum	300% minimum
Pinhole AQL	2.5	2.5
Powder-free	Per FDA recognized ASTM D6124-06	Residual Powder is 0.18mg (meets D6124-06)
Water Leakage Testing	Per US 21CFR 800.20	Yes
Biocompatibility	Per ISO 10993-1, 10993-5 and 10993-10	Not a Primary Skin Irritant; Not a Dermal Sensitizer

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

The document does not explicitly state the sample sizes used for each specific test (e.g., tensile strength, pinholes). It refers to compliance with recognized standards (ASTM D 5250-06 for physical properties, ASTM D 6124-06 for powder-free, US 21CFR 800.20 for water leakage, and ISO 10993-1, 10993-5, 10993-10 for biocompatibility). These standards typically define the sampling plans and testing methodologies. The provenance of the data is not specified beyond being "non-clinical testing" conducted by AmerCare Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device is an examination glove, and its performance is evaluated against material and physical property standards, not through expert-driven ground truth establishment of medical images or conditions.
Adjudication method for the test set:

This information is not applicable for this type of device and testing. Performance is measured against objective, standardized physical and chemical properties.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or assistive devices where human interpretation is involved. For an examination glove, the "effectiveness" is determined by its physical and material properties meeting established standards, not by human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical product (an examination glove), not an algorithm or a software device. The standalone performance refers to the device's physical and chemical attributes, which were tested.
The type of ground truth used:

The "ground truth" for the performance evaluation of the C2 Powder Free Polyethylene Examination Glove is based on recognized consensus standards for patient examination gloves. Specifically:
- ASTM D 5250-06: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application (applied to polyethylene gloves for substantial equivalence).
- ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- US 21 CFR 800.20: Water Leakage Test.
- ISO 10993-1, 10993-5, 10993-10: Biological evaluation of medical devices (for biocompatibility).
The sample size for the training set:

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:

This information is not applicable. There is no training set for this type of medical device.

Summary

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510(k) Summary for AmerCare C2 Powder Free Polyethylene Examination Glove

1. Submission Sponsor

AmerCare Inc. 7450 Industry Drive N. Charleston, SC 29418 United States Phone: 843-824-0550 Fax: 843-825-2550 Contact: Ty King, President and CEO FDA Establishment Registration #: 1053331

2. Submission Correspondent

AmerCare Inc. 7450 Industry Drive N. Charleston, SC 29418 United States Phone: 843-824-0550 Fax: 843-825-2550 Contact: Ty King, President and CEO FDA Establishment Registration #: 1053331

3. Date Prepared

Summary Prepared: April 5tt, 2012

4. Device Name

Trade/Proprietary Name: C2 Powder Free Polyethylene Examination Glove Common/Usual Name: Patient Examination Glove Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LZA Device Class: 1

Predicate Device

K110944 Non-sterile Powder Free Vinyl Patient Examination Gloves Clear (non)colored

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K113639

5. Device Description

Patient Examination glove - Disposable- Single use only - Non-sterile

The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.

Physical Dimensions	C2 Powder Free PolyethyleneExamination Gloves	FDA Recognized consensusstandard ASTM D 5250-06
Overall Length:	$255 \pm 5$ mm	230 mm minimum
Width:	$105 \pm 5$ mm (for large glove)	$105 \pm 5$ mm (for large glove)
Palm thickness:	.08mm minimum	.08mm minimum
Finger thickness:	.05mm minimum	.05mm minimum
Tensile Strength
Before Aging	11 MPa minimum	11 MPa minimum
After Aging	11 MPa minimum	11 MPa minimum
Ultimate Elongation
Before Aging	300% minimum	300% minimum
After Aging	300% minimum	300% minimum
Pinhole AQL	2.5	2.5

The AmerCare C2 Powder Free Polyethylene Examination Glove meets all current + specifications under ASTM 5250-06 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

6. Intended Use

Technological Characteristics and Substantial Equivalence

AmerCare Inc. believes that the C2 Powder Free Polyethylene Examination Gloves, 510(k) number K113639, are substantially equivalent to the predicate gloves manufactured by Wanga Plastic Co. Ltd., Powder Free Vinyl Examination Glove, 510(k) Number K110944. The proposed device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

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The properties of the C2 Powder Free Polyethylene Examination Glove and Wanga Plastic Co. Ltd., Powder Free Vinyl Examination Glove are compared in the following table. [The header repeats on each page.]

Manufacturer	AmerCare Inc.Proposed Glove	Wanga Plastic Co. Ltd.Predicate Glove	Proposed GloveCompared To WangaPredicate Glove
Trade name	C2 Powder Free Poly-ethylene ExaminationGlove	Powder Free VinylExamination Glove	Comparable
510(k) number	K113639	K110944
Product code	LZA	LYZ	Comparable
Regulation #	880.6250	880.6250	Same
Regulation name	Patient ExaminationGlove	Patient ExaminationGlove	Same
Indication for use	A powder-free, non-sterile patientexamination glove is adisposable deviceintended for medicalpurposes to be worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.	Non-sterile powder freevinyl patient examinationglove, Clear (noncolored)is a disposable deviceintended for medicalpurposes that is worn onthe examiner's handor finger to preventcontamination betweenpatient and examiner.	Comparable
Barrier FilmMaterial	Polyethylene	Vinyl	Comparable syntheticpolymer flexible barrierfilms
Color	Translucent [clear]	Translucent [clear]	Same
Biocompatible	Not a Primary SkinIrritant;Not a Dermal Sensitizer	Not a Primary SkinIrritation; Not a Dermalsensitization	Same
Powder-free	Powder-free per FDArecognized ASTMD6124-06	Powder-free per FDA rec-ognized ASTM D6124-06	Same
Physicalproperties	Per FDA recognizedASTM D 5250-06	Per FDA recognizedASTM D 5250-06	Same
Freedom fromPinholes	Yes,per FDA 21 CFR 800.20	Yes,Per FDA 21 CFR 800.20	Same
Sizes	S, M, L, XL and XXL	S, M, L and XL	Comparable

The C2 Powder Free Polyethylene Examination-Glove-from-AmerCare-Inc., shares the same or comparable indications for use, device operation, biocompatibility, freedom from pinholes, and functional capabilities; therefore, it is substantially equivalent to the predicate device.

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8. Non-Clinical Testing

Physical Testing per ASTM 5250-06 Standard Specification for Poly (vinyl chloride) . gloves for medical application
113639
Powder Free Per ASTM 6124-06 Procedure 1: Residual Powder is 0.18mg -�
Water Leakage Testing per US 21CFR 800.20 ●
Biocompatibility Testing per ISO 10993-1, 10993-5 and 10993-10 .

9. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.

10. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the AmerCare C2 Powder Free Polyethylene Examination Glove and the Wanga Plastic Co. Ltd., predicate glove do not raise any questions regarding its safety and effectiveness. The C2 Powder Free Polyethylene Examination Gloves, as designed and manufactured to yield a safe and effective barrier device, are determined to be substantially equivalent to the referenced predicate device.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 8 2012

Mr. Ty King President and CEO AmerCare Inc. 7450 Industry Drive N. Charleston, South Carolina 29418

Re: K113639

Trade/Device Name: C2 Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: March 28, 2012 Received: April 20, 2012

Dear Mr. King:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O. Arica

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K113639

Device Name: C2 Powder Free Polyethylene Examination Gloves

Indications For Use: A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use Over-The-Counter Use YES AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODB)

E.L.H.R. Ulam-William

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113639

IFU Page 1 of l

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.