(20 days)
Not Found
Not Found
No
The device is a surgical glove and the summary does not mention any AI/ML capabilities or related technologies.
No.
The device (surgical gloves) is intended to prevent contamination between personnel and patients, and to protect a surgical wound, which are preventive rather than therapeutic functions.
No
This device, a surgical glove, is intended to prevent contamination and protect wounds, not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical product (gloves) made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment, and for protecting a surgical wound. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material (natural rubber latex) and compliance with standards related to physical properties and safety for use as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Regulatory Classification: The predicate device is classified as "Class I Powder Free natural rubber latex Surgeon's gloves, 79KGO". The "KGO" product code is for "Gloves, Surgeon's". IVD devices have different product codes and regulatory classifications.
In summary, the purpose of these gloves is to provide a physical barrier for protection, not to perform any diagnostic testing.
N/A
Intended Use / Indications for Use
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are made of natural rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
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 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
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel, operating room personnel and similar personnel, 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 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 |
§ 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/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white on a black rounded rectangle. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in black. Below the text is the number "147817 V".
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
JAN 2 3 2002
510(k) SUMMARY
TEL +60-3-8706 1486 FAX +60-3-8706 1485 EML cyw_wrp@wrpworld.com URL www.wrpworld.com
1.0 Submitter:
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, |
| 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No .: | +60 3 8706 1486 |
| Fax No .: | +60 3 8706 1485 |
28 DEC 2001 Date of Summary Prepared:
Contact Person: 2.0
| 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 and
2. Multiple or Customer's Trade Name |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Polymer Coated Latex Surgical Gloves, Sterile
(Protein Labeling Claim) (50 microgram or Loss) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
Identification of The Legally Marketed Device: 4.0
Class I Powder Free natural rubber latex Surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 - 0111 Type 1 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.
Page 1 of 3 .
Your Partner In Protection™
1
WRP Asia Pacific Sdn Bhd
Intended Use of the Device: 6.0
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are made of natural rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Polymer Coated 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