(34 days)
Not Found
No
The device is a sterile latex examination glove, and the description focuses on material properties and regulatory compliance, with no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is described as examination gloves, intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical product (gloves) and not software. The 510(k) describes a change in labeling for a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and labeling of the gloves, not on any diagnostic function.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, this device is a medical glove, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Gloves, Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141.
The difference in this submission is:
- To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been established".
The device remains no change in product design and the additional claim 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 Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 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 or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 Examination Gloves, Sterile with Protein Content Labeling Claim will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
WRP WRP Asia Pacific Sdn Bhd
K030i57
FEB 1 9 2003
510(k) SUMMARY
| 4 7 8 1 7 V
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 |
1 4 JAN 2003 Date of Summary Prepared:
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No .: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Device Identification:
| Trade Name: | 1) Comfit, and
2) Multiple or Customers' Trade Name |
|----------------------|--------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Examination Gloves, Sterile with Protein
Content Labeling Claim |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
4.0 Identification of the Legally Marketed Device:
Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a52 and FDA 21 CFR 800.20.
5.0 Description of the Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141.
Page 1 of 3
Vour Partner In Protection
1
Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white inside of a black oval. To the right of the logo is the company name in black text. Below the company name is the number sequence "1 4 7 8 1 7 V".
The difference in this submission is:
- To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been
established".
The device remains no change in product design and the additional claim 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 Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.
6.0 Intended Use of the Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
7.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residual | ASTM D 6124 - 01 | Meets |