K Number
K980929
Device Name
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
Manufacturer
Date Cleared
1998-06-05

(85 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2. Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
More Information

Not Found

Not Found

No
The description focuses on the material and performance standards of surgical gloves, with no mention of AI or ML technology.

No.

This device, surgical gloves, is intended to protect a surgical wound from contamination, not to treat or diagnose a disease or condition.

No
Surgical gloves are protective devices, not diagnostic tools. They are designed to prevent contamination, not to diagnose medical conditions or provide information about a patient's health.

No

The device description clearly states it is made of synthetic rubber and is a physical glove, not software.

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

Here's why:

  • Intended Use: The intended use is to "be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used in vivo (on a living person) during a surgical procedure.
  • Device Description: The description confirms it's a "sterile disposable device intended to be worn by operating room personnel."
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a physical barrier used during surgery.

N/A

Intended Use / Indications for Use

A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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

KGO

Device Description

Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2.
Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CharacteristicsStandard
DimensionsMeets ASTM D 3577
Physical PropertiesMeets ASTM D 3577, Type 2
Freedom from holesMeets ASTM D 3577 Meets ASTM D 5151
Powder-FreeMeets described test in Attachment VI Meets ASTM D 6124 Not more than 2 mg residue by mass.
Biocompatability
Primary Skin Irritation in RabbitsPasses
Guinea Pig SensitizationPasses

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

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)

The performance test data of the non clinical tests are the same as mentioned immediately above.
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
It is concluded that Derma Prene® Powder-Free Synthetic Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.

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.

Not Found

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

5 1998 JUN

Checklist Section 21.0

Derma Prene® Powder-Free Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:

K980929

  • [1] 510 (k) Summary
  • [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646

Telephone: 330-833-2811 Fax: 330-833-6213

Contact: James R. Chatterton Telephone: 330-833-2811 Fax: 330-833-6213

March 12, 1998

  • [3] Trade Name: Derma Prene® Powder-Free Synthetic Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
  • [4] Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2.
  • [ર] Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
  • Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to [୧] be worn by operating room personnel to protect a surgical wound from contamination.
  • Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following [7] technological characteristics compared to ASTM or equivalent standards.
CharacteristicsStandard
DimensionsMeets ASTM D 3577
Physical PropertiesMeets ASTM D 3577, Type 2

CA

1

Derma Prene® Powder-Free Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:

Freedom from holes

Meets ASTM D 3577 Meets ASTM D 5151

Powder-Free Meets described test in Attachment VI Meets ASTM D 6124 Not more than 2 mg residue by mass.

Biocompatability
Primary Skin Irritation in RabbitsP
Guinea Pig SensitizationP

asses asses

  • The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
  • Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. િ
  • It is concluded that Derma Prene® Powder-Free Synthetic Surgical Gloves are as safe, as [10] effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

ASTM listed standards, FDA hole requirements, and labeling claims for the product.

  • This summary will include any other information reasonably deemed necessary by The FDA. [11]

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN B 1098

Mr. James R. Chatterton · Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646

Re: K980929 Derma Prene® Powder-Free Synthetic Surgical Trade Name: Gloves-Green Regulatory Class: I KGO Product Code: Dated: March 12, 1998 Received: March 12, 1998

Dear Mr. Chatterton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

3

Page 2 - Mr. Chatterton

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Timothy A. Ulatowski

Timoty A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

3.0 Indications for Use Statement:

INDICATIONS FOR USE

Applicant:Ansell Perry
510(K) Number (if known):K980929
Device Name:-Derma Prene@ Surgeon's Glove, powder free, polychloroprene - green
Indications For Use:

A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. him

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

.iption Use Per 21 CFR 801.109 OR

Over-The-Counter

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