(332 days)
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Not Found
No
The device description and performance data focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The gloves are intended to prevent contamination and are characterized by physical properties, not by a therapeutic effect on the body.
No
The device description clearly states it is a Class I latex patient examination glove, intended to prevent contamination. It does not mention any diagnostic function such as detecting, diagnosing, or monitoring a disease or health condition. Its performance studies and key metrics focus on the physical properties of the glove for protection, not on diagnostic capabilities.
No
The device is a physical glove, not software. The description details material properties and performance tests related to a physical product.
No, 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 environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical properties and standards met by the gloves, which are relevant to their barrier function and safety for the user, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical integrity of the gloves (watertightness, strength, dimensions) and their hypoallergenic properties, which are related to their function as a barrier and user safety, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This device is a personal protective equipment (PPE) item.
N/A
Intended Use / Indications for Use
The gloves are 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 to provent containmation between environment environment.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
Key Results:
- Watertight (1000 ml): Pass based on AQL of 2.5 (ASTM D 3578-91: S-4, AQL 4.0)
- Length (mm):
- Size XS: 275
- Size S: 287 (ASTM D 3578-91: min 230)
- Size M: 282 (ASTM D 3578-91: min 230)
- Size L: 284 (ASTM D 3578-91: min 230)
- Size XL: 275
- Palm width (mm):
- Size XS: 79
- Size S: 83 (ASTM D 3578-91: 80 ± 10)
- Size M: 93 (ASTM D 3578-91: 95 ± 10)
- Size L: 103 (ASTM D 3578-91: 111 ± 10)
- Size XL: 110
- Thickness (mm):
- Finger: 0.25 (ASTM D 3578-91: min 0.08)
- Palm: 0.22 (ASTM D 3578-91: min 0.08)
- Physical Properties Before Ageing:
- Tensile Strength (MPa): 30.0 (ASTM D 3578-91: min 21)
- Ultimate Elongation (%): 806 (ASTM D 3578-91: min 700)
- Physical Properties After Ageing:
- Tensile Strength (MPa): 28.1 (ASTM D 3578-91: min 16)
- Ultimate Elongation (%): 801 (ASTM D 3578-91: min 500)
- Powder Content: below 2 mg / glove
- Protein Content: below 50 microgram / gram
Clinical Performance:
- Study Type: Modified Draize test
- Sample Size: 200 Human subjects
- Key Results: demonstrated no potential for eliciting either dermal irritation or sensitization and support the labeling claim for "hypoallergenic".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "WRP" in a bold, sans-serif font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The logo is enclosed within a rounded, rectangular shape with a thick black border. The letters and the border are all black, creating a high-contrast image.
JUN 27 1996
Contact person WEMBLEY RUBE
Lot 1, Jalan 3
Kawasan Perusahaan Bandar Baru
Salak Tinggi, 43900 Sepang,
Selangor, Malaysia.
Corporate Office Tel: 8461486
8461867
Fax: 8461485
8481557
Factory Office: 8461495
8461496
Fax: 8461488
8461608
APPENDIX 4
510 (K) SUMMARY
-
- Trade Name COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, UNBEADED, PROTEIN LABELING CONTENT)
-
Common Name : Examination Gloves
-
Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I latex patient examination glove 80 L Y Y, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.
5. Description of device :
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.
6. Intended use of device :
The gloves are 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 to provent containmation between
environment environment.
Image /page/0/Picture/16 description: The image shows a circular logo with the text "REGISTERED" around the bottom half of the circle. Inside the circle is a symbol that looks like a heart with a line through the top, and a triangle pointing downwards. The logo is black and white and appears to be a stamp or seal.
Image /page/0/Picture/17 description: The image is a black and white circular logo. The logo has the words "REGISTERED MANUFACTURER" around the outside of the circle. Inside the circle is a large letter "A" with the letters "DH" below it.
Image /page/0/Picture/18 description: The image shows a black and white logo with the word "REGISTERED" in bold, sans-serif font. The word is placed inside a white, rounded diamond shape. The top and bottom portions of the diamond are black, creating a contrasting effect.
Page 1 of 3
1
7. Summary of Performance data
ﻴﺔ
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
There
| TEST | ASTM D 3578-91 | COMFIT Powder Free Latex Examination Gloves (Hypo, Unbeaded, Protein Labeling Content) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 |
| 2. Length (mm) | ||
| Size XS | - | 275 |
| Size S | min 230 | 287 |
| Size M | min 230 | 282 |
| Size L | min 230 | 284 |
| Size XL | - | 275 |
| 3. Palm width (mm) | ||
| Size XS | - | 79 |
| Size S | $80 \pm 10$ | 83 |
| Size M | $95 \pm 10$ | 93 |
| Size L | $111 \pm 10$ | 103 |
| Size XL | - | 110 |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.25 |
| Palm | min 0.08 | 0.22 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa) | min 21 | 30.0 |
| Ultimate Elongation (%) | min 700 | 806 |
| After Ageing: | ||
| Tensile Strength (MPa) | min 16 | 28.1 |
| Ultimate Elongation (%) | min 500 | 801 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Protein Content | - | below 50 microgram / gram |
2
8. Substantial Equivalence based on assessment of Non-Clinical performance data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram
9. Assessment of Clinical Performance data
Clinical data of 200 Human subjects on Modified Draize test done on this glove demonstrated no potential for eliciting either dermal irritation or sensitization and support the labeling claim for "hypoallergenic".
10. Conclusion
This glove exceed the ASTM D 3578-91 requirements, meet pinhole FDA requirements, meet Hypoallergenic labeling claim and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : 0 6 JIJN 1996