POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG

K110102 · Preventive Care, Inc. · LZA · May 13, 2011 · General Hospital

Device Facts

• Record ID: K110102
• Device Name: POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
• Applicant: Preventive Care, Inc.
• Product Code: LZA · General Hospital
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves coated with Allogel®. Available in blue, magenta, or copper. Worn on the hands by healthcare or similar personnel in clinical or examination settings. Acts as a physical barrier to prevent cross-contamination between the wearer and patients or handled substances. Performance verified through watertight testing, physical property testing (tensile strength, elongation), and biocompatibility assessments (skin irritation and sensitization).

Clinical Evidence

Bench testing only. Compliance with ASTM D6319-2010 and FDA watertight test (ASTM D5151) confirmed. Physical properties tested per ASTM D412 (tensile strength, elongation). Biocompatibility testing included Primary Skin Irritation and Guinea Pig Sensitization (Buehler) tests, which confirmed the device is not a sensitizer or irritant.

Technological Characteristics

Nitrile examination glove coated with Allogel®. Non-sterile, powder-free. Meets ASTM D6319-2010 standards for dimensions and physical properties. Barrier integrity verified via ASTM D5151 watertight test. Physical properties (tensile strength, elongation) tested per ASTM D412. Biocompatible (non-irritant, non-sensitizing).

Indications for Use

Indicated for use by healthcare or similar personnel as a disposable protective barrier worn on the hand to prevent cross-contamination between the wearer and the patient or substances handled.

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.

Submission Summary (Full Text)

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# 110102

MAY 1 3 2011

## PREVENTIVE CARE, INC.

#### 510(k) SUMMARY

- 1. Submitter: Preventive Care, Inc. 15215, Boulder Trail Rosemount, MN 55068, USA
- 2. Contact Name: Anil Segat
- 3. Phone: [phone]
- 4. Fax: [phone]
- ട്. E Mail: [e-mail]
- January 1000, 2011 6. Date of Preparation:
- 7. Device

,

| Trade Name: | Powderfree Nitrile Examination Gloves Coated with Allogel®, Blue, Magenta, Copper |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Examination Glove |
| Classification name: | Patient Examination Glove (Class1) |

- 8. Identification of legally marketed devices to which Equivalency is claimed:
- ರು. Intended use of device:

### 10. Summary of technological Characteristics compared to Predicate device:

Class 1 Powderfree Nitrile Examination Gloves, coated with Allogel®, colored, 80LZA, that meets all the applicable requirements of ASTM D6319-2010 and FDA water leak test Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled

There are no different technological characteristics compared to the predicate devices (detailed in Section 2 Form 3514) to which substantial equivalency is sought. They are all non sterile powderfree nitrile examination gloves (one coated with Allogel® Magenta color), with equivalent performance characteristics.

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KI10102

#### 11. Performance Data

Performance data of gloves based on ASTM D6319 and FDA Watertight test

| TEST | ASTM D6319<br>STANDARD<br>REQUIREMENT | POWDER FREE NITRILE EXAM<br>GLOVES COATED WITH<br>ALLOGEL® |
|-------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------|
| | | RESULTS |
| 1. Watertight (1000ml) in<br>accordance with ASTM<br>D 5151 | Multiple Normal in<br>accordance with ISO 2859 | |
| | GI<br>AQL=2.5 | Pass GI<br>AQL = 2.5 |
| 2. Length (mm) | | |
| Size<br>XS | Min 220 | 240 mm minimum for all sizes |
| S | Min 220 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | | |
| 3. Palm Width (mm) | | |
| Size<br>XS | 70 ± 10 | 75 - 80 |
| S | 80 ± 10 | 83 - 84 |
| M | 95 ± 10 | 94 - 96 |
| L | 110±10 | 107 - 109 |
| XL | 120±10 | 113 - 114 |
| 4. Thickness (mm)<br>(Single Layer) | | |
| Finger | Min 0.05 | Min 0.12 |
| Palm | Min 0.05 | Min 0.10 |
| Cuff | Min 0.05 | Min 0.08 |
| 5. Physical Properties<br>In accordance with<br>ASTM D 412 | | |
| Before Aging | Min 14 | 18 - 31 |

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K110102

| Tensile Strength(MPa)<br>Ultimate Elongation (%) | Min 500 | 530 - 600 |
|-----------------------------------------------------------------|-------------------|----------------------|
| After Aging<br>Tensile Strength(MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 400 | 18 - 29<br>500 - 550 |
| 6. Powder Content in<br>accordance with ASTM<br>D6124 | Max 2.0mg/glove | Below 2 mg/glove |

- The performance data of the glove as shown above meets the requirements of ASTM D6319, A. • including the Residual Powder requirement of max 2 mg per glove. Data of an actual representative shipment is detailed in Section 14
- The performance data above show that the Powderfree Nitrile Examination Gloves coated with B. : Allogel®, meet ASTM D 6319 requirements for Dimensions and Tolerances. Data of an actual representative shipment is detailed in Section 14
- ্ The performance data above show that the gloves meet ASTM D 6319 requirements of properties tested in accordance with ASTM D 412. Data of an actual representative shipment is detailed in Section 14
- D. The Biocompatibility Tests consist of (1) Primary Skin Irritation Test and (2) Guinea Pig Sensitization (Buehler) test. The test reports are detailed in Sections 8&9 The gloves have passed the Biocompatibility Test criteria of not being Sensitizers or Irritants.
- 12. Conclusion

.

We concluded that the Multiple Private Labeled, Powderfree Nitrile Examination Gloves coated with Allogel® in colors Blue, Magenta or Copper meet the requirements of:

- ASTM D-6319 and FDA requirements for:
- ੋ Watertight test for pinholes
- ் Physical properties
- 0 Dimensions
- ্ Residual Powders

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

MAY 1 3 2011

Ms. Anil Segat President Preventive Care, Incorporated 15215 Boulder Trail Rosemount, Minnesota 55068

Re: K110102

Trade/Device Name: Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 18, 2011 Received: March 24, 2011

Dear Ms. Segat:

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 Federal Register.

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#### Page 2- Ms. Segat

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hn for

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 Form

510(k) Number (if known): K110102

Device Name: : Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper)

Indications for Use:

An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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 (ODE)

Ellyabeth A. Clamitz Will

(ivision Sign-Off)

of Anesthesiology, General Hospital fection Control, Dental Devi

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510(k) Number: K110102