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K Number
K053272
Device Name
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
Manufacturer
Cardinal Health
Date Cleared
2006-01-05

(43 days)

Product Code
KGO
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera are formulated using Natural Rubber Latex. These are offered powder-free and sterile.
More Information

K001924

Not Found

No
The document describes surgical gloves and their performance characteristics, with no mention of AI or ML.

No
The gloves are intended to protect against contamination and perform medical procedures, not to treat or cure a disease or condition.

No
The description of the device as "surgical gloves" and its intended use "to protect a surgical wound from contamination" indicates it is a barrier device for medical procedures, not a diagnostic tool that identifies or assesses a disease or condition.

No

The device is described as surgical gloves, which are a physical product made of latex/nitrile, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that these gloves are for protecting a surgical wound from contamination and are worn by operating room personnel during medical procedures. This is a protective barrier function, not a diagnostic one.
  • Device Description: The description details the material and form of the gloves, which are consistent with a medical device used for protection.
  • Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
  • Performance Studies: The performance studies focus on the physical properties of the gloves (irritation, sensitization, strength, barrier defects, powder level), which are relevant to their function as a protective barrier, not a diagnostic tool.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device does not fit that description.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera are formulated using Natural Rubber Latex. These are offered powder-free and sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel / hospitals and other healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

TestResult
Primary Skin IrritationGloves are non-irritating.
Guinea Pig MaximizationGloves do not display any potential for sensitization.
Ultimate Elongation & Tensile StrengthGloves exceed requirements for rubber surgical gloves per ASTM D3577-01ae2.
Barrier DefectsGloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01ae2, AQL = 1.5.
Data/Test MethodGloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K001924

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4460 Non-powdered surgeon's glove.

(a)
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.(b)
Classification. Class I (general controls).

0

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of several curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.

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
Cardinal Health
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 578.2325 |
| Fax: | (847) 785-2461 |
| 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
Surgical Gloves (K001924) |
| Description: | Protegrity Blue Latex / Nitrile Surgical Gloves with
Neu-Thera are formulated using Natural Rubber
Latex. These are offered powder-free and sterile. |
| 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. |

1

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-
Thera are substantially equivalent to Protegrity Micro Sterile
Latex Surgical Gloves in that they provide the following
characteristics:

  • same intended use |
    |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
    | |

  • same sizes, product features

  • both made of Natural Rubber Latex using similar manufacturing process

Summary of Testing:

TestResult
Primary Skin IrritationGloves are non-irritating.
Guinea Pig MaximizationGloves do not display any potential for sensitization.
Ultimate Elongation
& Tensile StrengthGloves exceed requirements for rubber surgical gloves
per ASTM D3577-01ae2.
Barrier DefectsGloves exceed requirements per 21 CFR
§800.20 and ASTM D3577-01ae2, AQL = 1.5.
Data/Test MethodGloves meet powder level requirements for "Powder Free"
designation using ASTM Standard D6124-01-Standard test
method for residual powder on medical gloves. Results
generated values below 2 mg of residual powder per glove.

2

Image /page/2/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of four curved lines above the company name. The company name is written in a sans-serif font, with the words "Cardinal" and "Health" joined together.

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
same indication
statements? | YES: Protegrity Blue Latex Surgical Glove with Neu-
Thera has the identical intended use as Protegrity Micro
Sterile Latex Surgical glove. Both are intended to be
worn by operating room personnel to protect a surgical
wound from contamination. | Page 16-17 |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 5. Does new device have
same technological
characteristics? | YES: The answer is Yes for the following:
a) Coated Gloves and Protegrity Gloves are made
from a similar latex slurry and coagulant
formulation.
b) Both gloves are similar with regard to design,
namely size, physical form and hand specific
nature.
c) Both gloves are comparable with respect to the
requirements outlined in ASTM D3577-01ae2
d) Both gloves are sterile, powder-free and have
the protein labeling claim.
e) Both gloves are lubricated with CPC, silicone.
f) Both gloves have beaded cuffs.
g) Both gloves are made using triple dipping
technology that includes a nitrile coating. | Page 16-17 and
Attachment J |
| | NO: The answer is No for the following:
a) The colorants used in the manufacturing
process of the two products are different.
b) Neu-Thera Gloves are coated with Polymeric
Amino Sugar, Deacetylated Chitin (Hydagen
CMF), Citric Acid, Glycerol, D-Sorbitol, Provitamin
B-5 (Ritapan DL) , Glucono-delta-lactone
(Glucono-d-lactone), Triethyl Citrate (Hydagen
CAT), Sodium Citrate Dihydrate and Ammonium
salts of alkyl phosphate (Darvan L) | Pages 16-17 and
Attachment J |
| 7. Are the descriptive
characteristics precise
enough to ensure
equivalency? | YES: The physical testing performed indicates that the
product is acceptable. The predicate device comparison
table outlines the critical parameters of both gloves.
Given the products intended use, the descriptive
characteristics adequately demonstrate equivalency. | Pages 16-17 and
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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping lines or stripes, possibly representing an abstract human figure or a symbol of health and well-being.

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.

5

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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 847 785 2460

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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