Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier performance of surgical gloves, with no mention of AI or ML technologies.

Therapeutic

No
These gloves are intended to protect operating room personnel and maintain sterility of a surgical wound, not to treat or diagnose a disease or condition in a patient.

Diagnostic

No

Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly identifies the device as "Sterile Latex/Nitrile Surgical Gloves," which are physical hardware components. The summary also details performance studies related to the physical properties of the gloves (skin irritation, tensile strength, barrier defects, powder level). There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to protect a surgical wound from contamination and for use during medical procedures. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
Device Description: The description details the materials and features of surgical gloves, which are physical barriers.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the physical properties and safety of the gloves (irritation, sensitization, strength, barrier integrity, powder level), which are relevant to their function as a protective barrier.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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 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 Sterile Latex/Nitrile Surgical Gloves with brown colorant and coating are formulated using Natural Rubber Latex and Nitrile. These are offered powder-free and sterile. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant, proprietary coating (containg Chitosan, Provitamin B, Gluconolactone and Glycerol) and protein labeling claim (50 MICROGRAMS or Less)

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

environments within 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)

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:
Test: Primary Skin Irritation; Result: Gloves are non-irritating.
Test: Guinea Pig Maximization; Result: Gloves do not display any potential for sensitization.
Test: Ultimate Elongation & Tensile Strength; Result: Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2.
Test: Barrier Defects; Result: Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2.
Test: Data/Test Method; Result: Gloves 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.

Protegrity Sterile Latex Surgical Gloves

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K033905'. The characters are written in a clear, sans-serif font, and they appear to be part of a code or identification number. The image is simple and focuses solely on the alphanumeric sequence.

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
Cardinal Health
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 785-3337 |
| 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
brown colorant and coating are formulated using
Natural Rubber Latex and Nitrile. These are offered
powder-free and sterile. These latex gloves contain 50
micrograms or less of water extractable protein per
gram. |
| 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. |

1

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:

:

1

:

- - - - and the contraction of the comments of the control of : :

.

:

.

Test	Result
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization	Gloves do not display any potential for sensitization.
Ultimate Elongation
& Tensile Strength	Gloves exceed requirements for rubber surgical gloves
per ASTM D3577-01a2.
Barrier Defects	Gloves exceed requirements per 21 CFR
§800.20 and ASTM D3577-01a2.
Data/Test Method	Gloves 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/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. Inside the circle is an abstract image of an eagle.

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.

3

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 (301) 594-4618. 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/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

4

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,
proprietary coating (containg Chitosan, Provitamin B, Gluconolactone
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
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 latex gloves contain 50 micrograms or less of
water extractable protein per gram.
Prescription Use
(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use X
(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