(29 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is an examination glove, which is intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
Explanation: The device is a glove for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software.
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 device is a glove worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on meeting standards for examination gloves (ASTM D 3578 and FDA 21 CFR 800.20), which are not standards specific to IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body. This glove serves a protective barrier function.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are disposable devices 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 Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01°1 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 performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01ε1 | Meets |
| Physical Properties | ASTM D 3578 - 01ε1 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01ε1, FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 |
§ 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
JUN 1 1 2002
510(k) Summary
| 1.0 | Submitter: | K021561 |
|---|---|---|
| Name | WRP Specialty Products Sdn. Bhd. | |
| Address | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak | |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | ||
| Phone No. | +60 3 8706 9788 | |
| Fax No. | +60 3 8706 5022 |
Date of Summary Prepared April 8, 2002 :
2.0 Contact Person:
| Name: | Mr. V. Nadarajan |
|---|---|
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
3.0 Name of the device:
| Proprietary or Trade Name | : 1. | Dermagrip, and |
|---|---|---|
| : 2. | Multiple or Customer's Trade Name | |
| Classification Name | : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name | : | Powder Free Latex Examination |
| Glove, Sterile (Protein Content Labeling) |
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 - 0161 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01°1 and FDA 21 CFR 800.20.
1
6.0 Intended Use of the Device:
The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of the Technological Characteristics of the Device: 7.0
The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01ε1 | Meets |
| Physical Properties | ASTM D 3578 - 01ε1 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01ε1 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 - 00 |