(11 days)
Not Found
No
The 510(k) summary describes standard surgical gloves and does not mention any AI or ML components or functionalities.
No
The device, surgical gloves, is intended to prevent contamination and protect wounds, not to diagnose, treat, or prevent a disease or condition.
No
The device is a surgical glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical product (surgical gloves made of natural rubber latex) and describes physical characteristics and performance against ASTM standards, not software functionality.
Based on the provided information, 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. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the gloves, and their equivalence to a previously cleared surgical glove.
- Performance Studies: The performance studies evaluate the physical characteristics of the gloves (dimensions, physical properties, freedom from pinholes, powder residual, protein level, biocompatibility). These are tests related to the glove's function as a barrier and its safety for contact, not diagnostic performance.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body, detecting substances, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment. Surgical gloves do not perform this function.
N/A
Intended Use / Indications for Use
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.
The difference in this submission is: No colour additive is added.
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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 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
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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
CHARACTERISTICS: Dimensions; STANDARDS: ASTM D 3577 - 01aE2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Physical Properties; STANDARDS: ASTM D 3577 - 01aE2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Freedom from pinholes; STANDARDS: ASTM D 3577 - 01aE2, FDA 21 CFR 800.20; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Powder Residual; STANDARDS: ASTM D 6124 - 01; DEVICE PERFORMANCE: 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
WRP Asia Pacific Sdn Bhd 1 コフ良さアレ
AUG 2 2 2003
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 1557 |
Date of Summary Prepared: 0 7 AUG 2003
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No .: | +60 3 8706 1486 |
| Fax No .: | +60 3 8706 1557 |
3.0 Modified Device Identification:
| Trade Name: | 1) Aloetouch, and
2) Multiple or Customers' Trade Name |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) |
| 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 - 01a22 Type 1 and FDA 21 CFR 800.20.
Description of Device Modification: 5.0
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.
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Your Partner In Protection"
ATTACHMENT 1
1
WRP Asia Pacific Sdn Bhd '
The difference in this submission is:
1 4 7 8 1 7 V
- No colour additive is added. a)
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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.
Intended Use of the Device: 6.0
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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 Technological Characteristics for the Modified Device: 7.0
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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