(459 days)
Not Found
Not Found
No
The device is a standard latex examination glove and the summary contains no mention of AI or ML technology.
No.
The intended use of the gloves is for infection control by preventing contamination between personnel and patients, not for treating or diagnosing a medical condition.
No
Explanation: The device is a glove, intended for preventing contamination, not for diagnosing medical conditions. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of latex, which is a hardware component. The performance studies also focus on physical properties of the glove.
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 patients/their 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 glove. There is no mention of any components or functions related to analyzing samples or providing diagnostic information.
- Lack of IVD Indicators: The document lacks any of the typical characteristics of an IVD device submission, such as:
- Mention of analyzing biological samples (blood, urine, tissue, etc.).
- Description of reagents, assays, or analytical methods.
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc. in the context of a diagnostic test).
- Discussion of image processing, AI/ML, or imaging modalities, which are sometimes associated with certain types of IVDs (though not all).
The information provided describes a medical device used for barrier protection, specifically a patient examination glove.
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 and the patient's body, fluids, waste, or environment.
Product codes
LYY
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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
Key results in tabular form:
- Watertight (1000 ml): Pass based on AQL of 2.5 (ASTM S-4, AQL 4.0)
- Length (mm): Size XS: 240, Size S: 242 (min 230), Size M: 238 (min 230), Size L: 239 (min 230), Size XL: 240
- Palm width (mm): Size XS: 79, Size S: 85 (80 ± 10), Size M: 96 (95 ± 10), Size L: 105 (111 ± 10), Size XL: 110
- Thickness (mm): Finger: 0.25 (min 0.08), Palm: 0.19 (min 0.08)
- Physical Properties Before Ageing: Tensile Strength (MPa): 28.4 (min 21), Ultimate Elongation (%): 873 (min 700)
- Physical Properties After Ageing: Tensile Strength (MPa): 25.8 (min 16), Ultimate Elongation (%): 854 (min 500)
- Powder Content: below 2 mg / glove
- Protein Content: below 50 microgram / gram
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for detailed performance metrics.
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.
Not Found
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
OCT 11 1996
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are enclosed in a black, rounded rectangular border. The logo appears to be a simple, stylized design.
CONTACT PERSON: MR.
Wembley Rubber Products (M) Sdn Bhd
Marketing / Factory Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 SEPANG Selangor, Malaysia Telex: MA 39599 WRP Tel: +603-846 1486 Fax: +603-846 1557
APPENDIX 4
510 (K) SUMMARY
-
- Trade Name : COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, BEADED, PROTEIN LABELING CONTENT)
- : Examination Gloves 2. Common Name
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
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.
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 and the patient's body, fluids, waste, or environment.
Image /page/0/Picture/18 description: The image shows a black and white symbol that appears to be a stylized representation of a heart or an inverted triangle within a circular or semi-circular frame. The heart or triangle shape is positioned in the center of the frame, with a horizontal line across the top of the shape. The frame itself is thick and dark, with some irregularities or breaks in the outer edge, giving it a slightly distressed or worn appearance.
Image /page/0/Picture/19 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the letter 'A' in a circular fashion. The logo appears to be a stamp or seal, and the text is in a bold, sans-serif font.
Image /page/0/Picture/20 description: The image shows a black and white logo with the word "REGISTERED" in a sans-serif font. The logo is in the shape of a rounded pentagon. There is a thick black line at the bottom of the pentagon.
1
7. Summary of Performance data :
ು
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3578-91 | COMFIT Powder Free Latex
Examination Gloves (Hypo,
Beaded, Protein Labeling
Content) |
|-------------------------|----------------|-----------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 |
| 2. Length (mm) | | |
| Size XS | - | 240 |
| Size S | min 230 | 242 |
| Size M | min 230 | 238 |
| Size L | min 230 | 239 |
| Size XL | - | 240 |
| 3. Palm width (mm) | | |
| Size XS | - | 79 |
| Size S | $80 \pm 10$ | 85 |
| Size M | $95 \pm 10$ | 96 |
| Size L | $111 \pm 10$ | 105 |
| Size XL | - | 110 |
| 4. Thickness (mm) | | |
| Finger | min 0.08 | 0.25 |
| Palm | min 0.08 | 0.19 |
| 5. Physical Properties | | |
| Before Ageing: | | |
| Tensile Strength (MPa) | min 21 | 28.4 |
| Ultimate Elongation (%) | min 700 | 873 |
| After Ageing: | | |
| Tensile Strength (MPa) | min 16 | 25.8 |
| Ultimate Elongation (%) | min 500 | 854 |
| 6.Powder Content | - | below 2 mg / glove |
| 7.Protein Content | - | below 50 microgram / gram |
ﺮﺓ
Page 2 Of 3
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
...
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.
moves roquirements of 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 : June 05, 1996
Page 3 of 3