(18 days)
No
The device is a surgical glove, and the description focuses on its material, intended use, and performance against standards, with no mention of AI or ML.
No.
The device, a surgical glove, is intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic one that treats or prevents a disease/condition within the body.
No
The device, a surgical glove, is intended for protection from contamination, not for diagnosing any condition.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, not software.
Based on the provided text, 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 by being worn by surgeons and operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the material and physical characteristics of the glove.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
The device is clearly described as a surgical glove, which is a medical device used for protection and hygiene during surgical procedures.
N/A
Intended Use / Indications for Use
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates 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 Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour is equivalent to the exiting model, i.e. Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K032942.
The differences in this submission are
- With Aloe Vera coated on surgical gloves, a )
- Without colour additive, i.e. natural colour or ())
- With colour additive, i.e. turquoise (blue/green) colour ( )
- Colour additive is added for Turquoise (Blue/Green) Surgical Gloves and . will be subjected to design controls process whereby, risk assessment will be conducted to identify the hazards and estimate the risks of colour changed (Refer to Section 5 - Design Control Activities for the modified Device)
The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour meets all the requirements of ASTM standard D 3577 - 01a6 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 Polysoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are summarized with the following technological characteristics compared to ASTM or equivalent standards
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residual | 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 a bold, sans-serif font, with the "W" and "R" overlapping. The text "WRP Asia Pacific Sdn Bhd" is written in a smaller, sans-serif font to the right of the logo. The text is black and the background is white.
1 4 7 8 1 7 V
X040503
MAR 1 6 2004
SPECIAL 510(k) SUMMARY
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 |
25 FEB 2004 Date of Summary Prepared:
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No .: | +60 3 8706 1486 |
| Fax No .: | +60 3 8706 1485 |
Modified Device Identification: 3.0
| Trade Name: | 1) Aloetouch, and
2) Multiple or Customers' Trade Name |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free, Polymer Coated Polyisoprene Surgical Gloves,
Sterile, Coated with Aloe Vera, Natural colour or Turquoise
(Blue/Green) colour |
| 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 Synthetic rubber latex surgeon's gloves, 79KGO, that meets all Class Fromuer Free Dynanete D 3577 - 01a22 Type 2 and FDA 21 CFR 800.20.
.
Description of Device Modification: 5.0
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour is equivalent to the exiting model, i.e. Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K032942.
Vour Dartnar In Dentertinn"
1
Image /page/1/Picture/1 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, enclosed in a rounded, black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a smaller, black font. The text is aligned horizontally with the logo.
The differences in this submission are
- With Aloe Vera coated on surgical gloves, a )
- Without colour additive, i.e. natural colour or ())
- With colour additive, i.e. turquoise (blue/green) colour ( )
- Colour additive is added for Turquoise (Blue/Green) Surgical Gloves and . will be subjected to design controls process whereby, risk assessment will be conducted to identify the hazards and estimate the risks of colour changed (Refer to Section 5 - Design Control Activities for the modified Device)
The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour meets all the requirements of ASTM standard D 3577 - 01a6 and FDA 21 CFR 800 20
Intended Use of the Device: 6.0
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination
Summary of Technological Characteristics for the Modified Device: 7.0
The Powder Free, Polymer Coated Polysoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are summarized with the following technological characteristics compared to ASTM or equivalent standards
Page 2 of 3
Your Partner In Protection"
2
Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters arranged in a slightly overlapping fashion. To the right of the letters is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817V".
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residual | ASTM D 6124 - 01 | Meets |