(50 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination and is not designed to treat a medical condition or ailment, which is the primary function of a therapeutic device.
No
The device is a glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical glove, not software.
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/environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details a Class I latex patient examination glove, which is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the glove (watertightness, strength, dimensions) and its hypoallergenic properties, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
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)
80 LYY
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. Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is 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.)
Watertight (1000 ml): Pass based on AQL of 2.5
Length (mm): S: 297, M: 303, L: 300, XL: 293
Palm width (mm): S: 84, M: 95, L: 105, XL: 118
Thickness (mm): Finger: 0.40, Palm: 0.30
Before Ageing: Tensile Strength (MPa): 31.23, Ultimate Elongation (%): 895
After Ageing: Tensile Strength (MPa): 26.64, Ultimate Elongation (%): 946
Powder Content: below 2 mg / glove
Protein Content: below 50 microgram / gram
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 "WKR" in bold, black font. The letters are arranged horizontally, with "W" on the left, "K" in the middle, and "R" on the right. A thick, black line forms a semi-circular shape below the letters, creating a border around the logo. The logo appears to be a stylized design, possibly representing a company or organization with the initials "WKR".
CONTACT PERSON
(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
8461608
510 (K) SUMMARY
- Trade Name : COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
-
- Common Name : Examination Gloves
-
- 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/14 description: The image shows a logo for a registered firm that meets the BS EN ISO 9002:1994 standards. The logo is circular with the letters "BSI" at the top. Inside the circle is a heart shape. The words "REGISTERED FIRM" are written around the circle.
Image /page/0/Picture/15 description: The image is a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the top half of the circle, and 'OH' is located at the bottom. The logo appears to be a stamp or seal, possibly indicating registration or certification of a manufacturer.
GOOD MANUFACTURING PRACTICE
UK DEPARTMENT OF HEALTH
REGISTRATION NO. R0589/SP
Image /page/0/Picture/17 description: The image shows a logo with the word "REGISTERED" in a white oval shape. The oval is placed in the center of a diamond shape. The top and bottom triangles of the diamond are shaded in black. The word "MALAYSIA" is written below the diamond shape.
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 Blue
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 | - | - |
| S | min 230 | 297 |
| M | min 230 | 303 |
| L | min 230 | 300 |
| XL | - | 293 |
| 3. Palm width (mm) | | |
| Size | | |
| XS | - | - |
| S | 80 ± 10 | 84 |
| M | 95 ± 10 | 95 |
| L | 111 ± 10 | 105 |
| XL | - | 118 |
| 4. Thickness (mm) | | |
| Finger | min 0.08 | 0.40 |
| Palm | min 0.08 | 0.30 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 21 | 31.23 |
| Ultimate Elongation (%) | min 700 | 895 |
| After Ageing : | | |
| Tensile Strength (MPa) | min 16 | 26.64 |
| Ultimate Elongation (%) | min 500 | 946 |
| 6.Powder Content | - | below 2 mg / glove |
| 7.Protein Content | - | below 50 microgram / gram |
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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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