(316 days)
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No
The document describes a standard patient examination glove and makes no mention of AI or ML technology.
No.
The device description states it is a glove used to prevent contamination, which is a barrier function, not a therapeutic action.
No
The device is a patient examination glove, worn on the examiner's hand to prevent contamination. Its function is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is worn on the hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on material, standards compliance, and protein content, all related to the physical properties and safety of the glove as a barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim are disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications For Use:
The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 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 Coated with Vitamin E, and 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-Free | ASTM D 6124 - 01 |
§ 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
MAY 11 2004
510(k) Summary
1.0 Submitter:
| Name: | WRP Specialty Products Sdn Bhd. |
|---|---|
| Address: | Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
Date of Summary Prepared:
2.0 Contact Person:
| Name: | 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-X, and |
|---|---|
| 2) Multiple or Customer's Trade Name | |
| Classification Name : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name : | Powder Free Latex Examination Gloves Coated with |
| Vitamin E, and with Protein Content Labeling Claim | |
| (50 Micrograms or less) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a 22 and FDA 21 CFR 800.20.
Description of The Device: 5.0
:
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.
1
Intended Use of the Device: 6.0
The Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim are disposable device 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 Gloves Coated with Vitamin E, and 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-Free | ASTM D 6124 - 01 | ✓ |
| ------------------------------------------ | ------------------------------------------------------------------------------------ | |
| Kei Mulry | ||
| (Division Sign-Off) | ||
| Division of Anesthesiology, General Hospital, | ||
| Infection Control, Dental Devices | ||
| 510(k) Number: | K032016 |
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