PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING

K033905 · Cardinalhealth · KGO · Apr 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033905
• Device Name: PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
• Applicant: Cardinalhealth
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant and coating are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, powder-free surgical gloves composed of natural rubber latex and nitrile; feature brown colorant and proprietary coating containing chitosan, provitamin B, gluconolactone, and glycerol. Used by operating room personnel in hospitals and healthcare facilities during invasive and non-invasive procedures to maintain sterile field and protect surgical wounds from contamination. Protein content labeled at 50 micrograms or less per gram. Device provides physical barrier protection.

Clinical Evidence

Bench testing only. Testing included primary skin irritation (non-irritating), Guinea Pig Maximization (no sensitization potential), ultimate elongation and tensile strength (exceeds ASTM D3577-01a2), barrier defects (exceeds 21 CFR 800.20 and ASTM D3577-01a2), and residual powder levels (meets ASTM D6124-01).

Technological Characteristics

Materials: Natural rubber latex and nitrile. Coating: Chitosan, provitamin B, gluconolactone, glycerol. Form factor: Sterile, powder-free surgical glove. Standards: ASTM D3577-01a2 (tensile/elongation/barrier), ASTM D6124-01 (residual powder), 21 CFR 800.20 (barrier).

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination during invasive and non-invasive medical procedures in hospital and healthcare facility environments.

Regulatory Classification

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.

Predicate Devices

• Protegrity Sterile Latex Surgical Gloves

Submission Summary (Full Text)

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### APR 2 7 2004

# XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEGRITY STERILE LATEXNITRILE SURGICAL GLOVES WITH BROWN COLORANT, COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) AND PROTEIN LABELING CLAIM

| Regulatory Affairs Contact: | Erica Sethi<br>Cardinal Health<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Date Summary Prepared: | 4/26/04 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Protegrity Sterile Latex Surgical Gloves |
| Description: | Protegrity Sterile Latex/Nitrile Surgical Gloves with<br>brown colorant and coating are formulated using<br>Natural Rubber Latex and Nitrile. These are offered<br>powder-free and sterile. These latex gloves contain 50<br>micrograms or less of water extractable protein per<br>gram. |
| Intended Use: | Protegrity Sterile Latex/Nitrile Surgical Gloves with<br>brown colorant and coating are intended for use in<br>environments within hospitals and other healthcare<br>facilities. The gloves are appropriate for use during<br>invasive and non-invasive medical procedures requiring<br>sterility. They are intended to be worn by operating<br>room personnel to protect a surgical wound from<br>contamination. |

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# K033905

### : 上一篇:

#### Substantial Equivalence: Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant and coating are substantially equivalent to Protegrity Sterile Latex Surgical Gloves in that they provide the following ・ characteristics:

- same intended use

- same sizes, product features, packaging

- both made of Natural Rubber Latex and Nitrile using similar manufacturing process

## Summary of Testing:

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| Test | Result |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Ultimate Elongation<br>& Tensile Strength | Gloves exceed requirements for rubber surgical gloves<br>per ASTM D3577-01a2. |
| Barrier Defects | Gloves exceed requirements per 21 CFR<br>§800.20 and ASTM D3577-01a2. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free"<br>designation using ASTM Standard D6124-01-Standard test<br>method for residual powder on medical gloves. Results<br>generated values below 2 mg of residual powder per glove. |

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Cardinal Health Ms. Erica Sethi Manager, Regulatory Affairs Medical Product and Scrvices 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K033905

Trade/Device Name: Protegrity Sterile Latex/Nitrile Surgical Gloves with Proprietary Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol) with Protein Content Labeling Claim (50 Micrograms or Less) & Brown Coloring Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 4, 2004 Received: March 5, 2004

Dear Ms. Sethi:

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 - Ms. Sethi

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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মুম CardinalHealth

> 1500 Waukagan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847,785.2460

| | | Page 1 of 1 | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--|
| Applicant: | Cardinal Health | | |
| 510(k) Number: | K033905 | | |
| Device Name: | Undetermined | | |
| Device description: | Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant,<br>proprietary coating (containg Chitosan, Provitamin B, Gluconolactone<br>and Glycerol) and protein labeling claim (50 MICROGRAMS or Less) | | |
| Indications For Use: | These gloves are intended to be worn by operating room personnel to<br>protect a surgical wound from contamination in environments within<br>hospitals and other healthcare facilities. The gloves are appropriate for<br>use during invasive as well as non-invasive medical procedures<br>requiring sterility. These latex gloves contain 50 micrograms or less of<br>water extractable protein per gram. | | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use X<br>(21 CFR 807 Subpart C) | |

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Mulvey

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

510(k) Number: K033905