(50 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and performance of a latex glove, with no mention of AI or ML technology.
No.
The device is intended to prevent contamination between healthcare personnel and patients, fluids, or environment, which positions it as a barrier for infection control rather than a device used to treat or diagnose a disease or condition.
No
The device, a patient examination glove, is intended for barrier protection to prevent contamination, not for diagnosing medical conditions.
No
The device is a physical glove, not software. The description clearly outlines a hardware product (latex glove) and its physical properties and performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and patients/environment. This is a barrier function, not a diagnostic function.
- Device Description: It's a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the glove (watertightness, strength, etc.) and its hypoallergenic properties, not on diagnostic accuracy.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, 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
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
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 include:
- Watertight (1000 ml): Pass based on AQL of 2.5
- Length (mm): Size XS: 249, S: 249, M: 249, L: 249, XL: 251. All meet or exceed min 230 for S, M, L.
- Palm width (mm): Size XS: 79, S: 85, M: 96, L: 105, XL: 110. All within ASTM D 3578-91 range (e.g. 80 +/- 10 for S).
- Thickness (mm): Finger: 0.22, Palm: 0.16. Both exceed min 0.08.
- Physical Properties:
- Before Ageing: Tensile Strength (MPa): 35.03 (min 21), Ultimate Elongation (%): 868 (min 700).
- After Ageing: Tensile Strength (MPa): 29.85 (min 16), Ultimate Elongation (%): 826 (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 metrics. Key metrics include AQL for watertight test, length, palm width, thickness, tensile strength, ultimate elongation, powder content, and protein content.
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 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
Image /page/0/Picture/0 description: The image shows a logo with the letters "WKT" in bold, black font. The letters are stylized and connected, with the "T" having a unique, curved extension. A thick, black line forms a bracket shape around the letters, enclosing them within the logo design.
CONTACT PERSON: WEMBLEY RUBB
JI 26 K
(M) SDN BHD
Lot 1, Jalan 3
awasan Perusahaan Bandar Baru
Salak Tinggi, 43900 Sepang,
Selangor, Malaysia.
Corporate Office Tel: 8461486
8461867
Fax: 8461485
8461557
Factory Office: 8461495
8461496
Fax: 8461488
846160R
510 (K) SUMMARY
: COMFIT POWDER FREE GREEN EXAMINATION 1. Trade Name GLOVES (HYPOALLERGENIC, LOW PROTEIN)
- : Examination Gloves 2. Common Name
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, 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, low protein, 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.
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Image /page/0/Picture/16 description: The image is a logo for a registered firm that is certified under the BS EN ISO 9002: 1994 standard. The logo consists of a circle with the words "REGISTERED FIRM" around the edge. Inside the circle is a symbol that looks like a heart. The text "BS EN ISO 9002: 1994" is printed below the logo, along with the words "BRITISH STANDARDS INSTITUTION".
BS EN ISO 9002 : 1994
BRITISH STANDARDS INSTITUTION
REGISTRATION NO: FM 13934
Image /page/0/Picture/18 description: The image is a circular logo with the letters 'DH' at the bottom. The letter 'A' is in the center of the logo. The words 'REGISTERED MANUFACTURER' are written around the top of the circle. The words 'MANUFACTURING PRACTICE' are written at the bottom of the image.
GOOD MANUFACTURING PRACTICE
UK DEPARTMENT OF HEALTH
REGISTRATION NO: R0589/SP
Image /page/0/Picture/20 description: The image shows a black and white logo with the word "REGISTERED" in the center. The word is inside of a white oval shape. The oval is inside of a diamond shape, with the top and bottom triangles of the diamond being black with white diagonal lines.
MALAYSIA
QUALITY SYSTEM MS ISO 9002 : 1991
REGISTRATION NO: AR 0027
1
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3578-91 | COMFIT Powder Free Green
Examination Gloves
(Hypoallergenic,Low Protein)
Pass based on AQL of 2.5 |
|-------------------------|----------------|------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | |
| 2. Length (mm). | | |
| Size XS | - | 249 |
| S | min 230 | 249 |
| M | min 230 | 249 |
| L | min 230 | 249 |
| XL | - | 251 |
| 3. Palm width (mm) | | |
| Size XS | - | 79 |
| S | $80 \pm 10$ | 85 |
| M | $95 \pm 10$ | 96 |
| L | $111 \pm 10$ | 105 |
| XL | - | 110 |
| 4. Thickness (mm) | | |
| Finger | min 0.08 | 0.22 |
| Palm | min 0.08 | 0.16 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 21 | 35.03 |
| Ultimate Elongation (%) | min 700 | 868 |
| After Ageing : | | |
| Tensile Strength (MPa) | min 16 | 29.85 |
| Ultimate Elongation (%) | min 500 | 826 |
| 6.Powder Content | - | below 2 mg / glove |
| 7.Protein Content | - | below 50 microgram / gram |
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t
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 : May 27, 1996
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