CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES

K053272 · Cardinalhealth · KGO · Jan 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053272
• Device Name: CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
• Applicant: Cardinalhealth
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera 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. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Device Story

Protegrity Blue Latex/Nitrile Surgical Gloves are sterile, powder-free, natural rubber latex gloves featuring a proprietary 'Neu-Thera' coating (containing chitosan, provitamin B5, gluconolactone, and glycerol) and a blue colorant. The gloves are manufactured using a triple-dipping process that incorporates a nitrile coating. They are intended for use by operating room personnel in hospitals and healthcare facilities to maintain a sterile field and protect surgical wounds from contamination during medical procedures. The device is a single-use, disposable item. The healthcare provider dons the gloves manually; the Neu-Thera coating is designed to improve wet donning properties. The device provides a physical barrier to prevent cross-contamination between the wearer and the patient.

Clinical Evidence

Bench testing only. Testing included primary skin irritation and guinea pig maximization (sensitization) studies, which showed the gloves are non-irritating and non-sensitizing. Physical performance testing confirmed compliance with ASTM D3577-01ae2 for ultimate elongation, tensile strength, and barrier defects (AQL = 1.5). Residual powder levels were tested per ASTM D6124-01, confirming levels below 2 mg per glove. Protein content was verified to be 50 micrograms or less of water-extractable protein per gram.

Technological Characteristics

Natural rubber latex surgical gloves with a nitrile coating. Features a proprietary Neu-Thera coating (chitosan, provitamin B5, gluconolactone, glycerol, citric acid, triethyl citrate, sodium citrate dihydrate, ammonium salts of alkyl phosphate). Beaded cuffs. Sterile, powder-free. Conforms to ASTM D3577-01ae2 and ASTM D6124-01. Triple-dipping manufacturing process.

Indications for Use

Indicated for use by operating room personnel in hospitals and healthcare facilities to protect surgical wounds from contamination during invasive and non-invasive sterile medical procedures.

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 Micro Sterile Latex Surgical Gloves (K001924)

Submission Summary (Full Text)

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JAN 5 -2006

# SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEGRITY BLUE LATEX / NITRILE SURGICAL GLOVES WITH NEU THERA

| Regulatory Affairs Contact: | Amy Hoyd<br>Cardinal Health<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Summary Prepared: | 11/14/05 |
| Product Trade Name: | Protegrity Blue with Neu-Thera |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Cardinal Health's Protegrity Micro Sterile Latex<br>Surgical Gloves (K001924) |
| Description: | Protegrity Blue Latex / Nitrile Surgical Gloves with<br>Neu-Thera are formulated using Natural Rubber<br>Latex. These are offered powder-free and sterile. |
| Intended Use: | Protegrity Blue Latex / Nitrile Surgical Gloves with<br>Neu-Thera are intended for use in environments<br>within hospitals and other healthcare facilities. The<br>gloves are appropriate for use during invasive and<br>non-invasive medical procedures requiring sterility.<br>They are intended to be worn by operating room<br>personnel to protect a surgical wound from<br>contamination. These latex gloves contain 50<br>micrograms or less of water extractable protein per<br>gram. |

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Image /page/1/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge at a point, resembling a bird in flight or abstract wings. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter of each word capitalized.

# SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEGRITY BLUE LATEX / NITRILE SURGICAL GLOVES WITH NEU-THERA continued

| Substantial Equivalence: Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-<br>Thera are substantially equivalent to Protegrity Micro Sterile<br>Latex Surgical Gloves in that they provide the following<br>characteristics:<br>- same intended use |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| |

- same sizes, product features
- both made of Natural Rubber Latex using similar manufacturing process

Summary of Testing:

| 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 D3577-01ae2. |
| Barrier Defects | Gloves exceed requirements per 21 CFR<br>§800.20 and ASTM D3577-01ae2, AQL = 1.5. |
| 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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# SUMMARY OF SUBSTANTIAL EQUIVALENCE CON'T 510(k) S. E. DECISION SUMMARY PROTEGRITY MICRO STERILE LATEX SURGICAL GLOVES (K001924) vs. PROTEGRITY BLUE LATEX / NITRILE SURGICAL GLOVES WITH NEU-THERA

#### QUESTION

### SUMMARY RESPONSE

REFERENCE

KO53272

| 3. Does new device have<br>same indication<br>statements? | YES: Protegrity Blue Latex Surgical Glove with Neu-<br>Thera has the identical intended use as Protegrity Micro<br>Sterile Latex Surgical glove. Both are intended to be<br>worn by operating room personnel to protect a surgical<br>wound from contamination. | Page 16-17 |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 5. Does new device have<br>same technological<br>characteristics? | YES: The answer is Yes for the following:<br>a) Coated Gloves and Protegrity Gloves are made<br>from a similar latex slurry and coagulant<br>formulation.<br>b) Both gloves are similar with regard to design,<br>namely size, physical form and hand specific<br>nature.<br>c) Both gloves are comparable with respect to the<br>requirements outlined in ASTM D3577-01ae2<br>d) Both gloves are sterile, powder-free and have<br>the protein labeling claim.<br>e) Both gloves are lubricated with CPC, silicone.<br>f) Both gloves have beaded cuffs.<br>g) Both gloves are made using triple dipping<br>technology that includes a nitrile coating. | Page 16-17 and<br>Attachment J |
| | NO: The answer is No for the following:<br>a) The colorants used in the manufacturing<br>process of the two products are different.<br>b) Neu-Thera Gloves are coated with Polymeric<br>Amino Sugar, Deacetylated Chitin (Hydagen<br>CMF), Citric Acid, Glycerol, D-Sorbitol, Provitamin<br>B-5 (Ritapan DL) , Glucono-delta-lactone<br>(Glucono-d-lactone), Triethyl Citrate (Hydagen<br>CAT), Sodium Citrate Dihydrate and Ammonium<br>salts of alkyl phosphate (Darvan L) | Pages 16-17 and<br>Attachment J |
| 7. Are the descriptive<br>characteristics precise<br>enough to ensure<br>equivalency? | YES: The physical testing performed indicates that the<br>product is acceptable. The predicate device comparison<br>table outlines the critical parameters of both gloves.<br>Given the products intended use, the descriptive<br>characteristics adequately demonstrate equivalency. | Pages 16-17 and<br>Attachment J |

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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge towards the left, resembling abstract wings or paths.

# MANUFACTURE'S STATEMENT OF SUBSTANTIAL EQUIVALENCE

(To be provided with 510(k) notifications for tier 1 devices)

003272

## STATEMENT OF INDICATIONS FOR USE:

Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera are designed for use during invasive and non-invasive medical procedures requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 ming rooms or less of water extractable protein per gram.

### CLAIMS:

Protegrity Blue Latex / Nitrile Surgica! Gloves with Neu-Thera:

Sterile, powder-free, for single use only, contains natural rubber latex

- * Sterile, powder-free, for single use only
- * This latex glove contains 50 micrograms or less of total water extractable protein per gram
- * Glove provides superior wet donning properties for easy donning

This notification contains all of the information required by 21 CFR §807.87. A completed copy of the "Premarket Notification 510(k) Reviewer's Screening Checklist" is included with this submission.

The subject device conforms to the following voluntary and mandatory standards:

Good Manufacturing Practices, ASTM Standard D3577-99.

The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and intended use are equivalent.

The above statements are accurate representations of this 510(k) premarket notification and of the device this firm intends to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted (21 CFR §807.87 (j)).

MANUFACTURER:

CARDINAL HEALTH

OFFICIAL CORRESPONDENT:

Amy Heipl

Amy Hoyd (printed name) TITLE: Regulatory Affairs Manager DATE: 26, December 2005

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 5 2006

Cardinal Health C/O Ms. Amy Hoyd Regulatory Affairs Manager Medical Products and Services 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K053272

Trade/Device Name: Protegrity Sterile Latex/Nitrile Surgical Gloves with Blue Colorant and Neu-Thera Proprietary Coating (Containing Chitosan, ProVitamin B5, Gluconolactone and Glycerol) and Protein Labeling Claim of 50 Micrograms or Less Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 16, 2005 Received: December 13, 2005

#### Dear Ms. Hoyd:

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. Hoyd

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/industry/support/index.html.

Sincerely vours.

Smutie y. Michael Oms.

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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Image /page/6/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of three curved lines that resemble abstract bird wings or flight paths. The text "CardinalHealth" is written in a simple, sans-serif font, with the first letter capitalized and the rest in lowercase.

1500 Waukegan Road McGaw Park, Illinois 60085-6787 FAX [phone]

# 3.0 Indications for Use Statement

510(k) Number: (if known): K053272

- Device Name: Protegrity Sterile Latex/Nitrile Surgical Gloves with blue colorant and Neu-Thera proprietary coating (containing Chitosan, ProVitamin B5, Gluconolactone and Glycerol) and protein labeling claim of 50 micrograms or less. Indications For Use: These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. These gloves contain 50 micrograms or less of water extractable protein per gram.
Prescription Use Over-The Counter Use AND/OR × ( 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuly A. Murphy, B. 1/4/04

General Hospital
Dental Devices

K 053272
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