K Number
K021784
Device Name
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
Date Cleared
2002-07-24

(55 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Device Description
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.
More Information

Not Found

Not Found

No
The document describes a standard surgical glove and contains no mention of AI or ML technology.

No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.

No

The device description indicates it is a surgeon's glove, intended to protect a surgical wound from contamination, not to diagnose a condition.

No

The device is a physical surgical glove made of latex, not software. The description focuses on material properties and physical standards.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the glove is for protecting a surgical wound from contamination by being worn by surgeons and operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description focuses on the physical properties and standards the glove meets (ASTM, FDA regulations for gloves).
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.

IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical glove does not fit that description.

N/A

Intended Use / Indications for Use

The Powder Free Polymer Coated Brown Latex Surgical Glove, Sterile (Protein Labeling Claim) is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination,

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

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

KGO

Device Description

The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.

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

surgeons and/or 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 Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICSSTANDARDSDEVICE PERFORMANCE
DimensionsASTM D 3577 - 01E1Meets
Physical PropertiesASTM D 3577 - 01E1Meets
Freedom from pinholesASTM D 3577 - 01E1 FDA 21 CFR 800.20Meets
Powder-FreeASTM D 6124 - 01Meets 2 mg/glove maximum
Protein LevelASTM D 5712 – 95

§ 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

WRP Asia Pacific Sdn Bhd

JUL 2 4 2002

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

510(k) SUMMARY

K021784

+60-3-8706 1486 TEL +60-3-8706 1485 FAX cyw wrp@wrpworld.com www.wrpworld.com

1.0 Submitter:

Name:WRP Asia Pacific Sdn Bhd
Address:Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak
Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:+60 3 8706 1486
Fax No.:+60 3 8706 1485

27 MAY 2002 Date of Summary Prepared:

2.0 Contact Person:

Name:Mr. Yue Wah, CHOW
Phone No.:+60 3 8706 1486
Fax No.:+60 3 8706 1485

3.0 Name of the device:

| Trade Name: | 1. Profeel
2. Multiple or Customer's Trade Name |
|----------------------|--------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Polymer Coated Brown Latex Surgical Gloves
Sterile (Protein Labeling Claim) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |

4.0 Identification of The Legally Marketed Device:

Class I Powder Free natural rubber latex Surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 0181 Type 1 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.

Com

1

WRP Asia Pacific Sdn Bhd 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1

Intended Use of the Device: 6.0

The Powder Free Polymer Coated Brown Latex Surgical Glove, Sterile (Protein Labeling Claim) is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination,

Summary of The Technological Characteristics of The Device: 7.0

The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Dimensions | ASTM D 3577 - 01E1 | Meets |
| Physical Properties | ASTM D 3577 - 01E1 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01E1
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets
2 mg/glove maximum |
| Protein Level | ASTM D 5712 – 95 |