C2 MEDICAL GLOVES

K113639 · Amercare, Inc. · LZA · May 8, 2012 · General Hospital

Device Facts

• Record ID: K113639
• Device Name: C2 MEDICAL GLOVES
• Applicant: Amercare, Inc.
• Product Code: LZA · General Hospital
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

C2 Powder Free Polyethylene Examination Glove is a disposable, non-sterile, translucent, low-density polyethylene barrier device. Worn on examiner's hand or finger; prevents contamination between patient and examiner. Available in sizes S, M, L, XL, and XXL. Device functions as a flexible physical barrier. Used in clinical settings; operated by healthcare professionals. Benefits patient and examiner by reducing risk of cross-contamination during examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including physical dimensions, tensile strength, ultimate elongation, pinhole AQL (2.5), and biocompatibility (ISO 10993-1, 10993-5, 10993-10).

Technological Characteristics

Material: Low-density polyethylene. Form factor: Loose-fitting, translucent, disposable glove. Dimensions: 255mm length, 0.08mm palm thickness, 0.05mm finger thickness. Standards: ASTM D5250-06 (physical properties), ASTM D6124-06 (powder-free), 21 CFR 800.20 (pinholes). Biocompatibility: Non-irritant, non-sensitizer.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner. Suitable for general medical purposes.

Regulatory Classification

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 Vinyl Examination Glove (K110944)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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: [phone] Fax: [phone] 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 Polyethylene<br>Examination Gloves | FDA Recognized consensus<br>standard 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

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.

7. 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.<br>Proposed Glove | Wanga Plastic Co. Ltd.<br>Predicate Glove | Proposed Glove<br>Compared To Wanga<br>Predicate Glove |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Trade name | C2 Powder Free Poly-<br>ethylene Examination<br>Glove | Powder Free Vinyl<br>Examination Glove | Comparable |
| 510(k) number | K113639 | K110944 | |
| Product code | LZA | LYZ | Comparable |
| Regulation # | 880.6250 | 880.6250 | Same |
| Regulation name | Patient Examination<br>Glove | Patient Examination<br>Glove | Same |
| Indication for use | A powder-free, non-<br>sterile patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes to be worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | Non-sterile powder free<br>vinyl patient examination<br>glove, Clear (noncolored)<br>is a disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. | Comparable |
| Barrier Film<br>Material | Polyethylene | Vinyl | Comparable synthetic<br>polymer flexible barrier<br>films |
| Color | Translucent [clear] | Translucent [clear] | Same |
| Biocompatible | Not a Primary Skin<br>Irritant;<br>Not a Dermal Sensitizer | Not a Primary Skin<br>Irritation; Not a Dermal<br>sensitization | Same |
| Powder-free | Powder-free per FDA<br>recognized ASTM<br>D6124-06 | Powder-free per FDA rec-<br>ognized ASTM D6124-06 | Same |
| Physical<br>properties | Per FDA recognized<br>ASTM D 5250-06 | Per FDA recognized<br>ASTM D 5250-06 | Same |
| Freedom from<br>Pinholes | Yes,<br>per FDA 21 CFR 800.20 | Yes,<br>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 [phone] or [phone] 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

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