(88 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of surgical gloves, with no mention of AI or ML technologies.
No
The device, a surgical glove, is intended to prevent contamination between healthcare personnel and patients, not to treat or cure a disease or condition. Its purpose is protective, not therapeutic.
No
Explanation: The device is a surgical glove intended for personal protection and contamination prevention, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of natural rubber latex, 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/their environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and materials of the glove, designed for protection and durability in a surgical setting.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical integrity and hypoallergenic properties of the glove, not on diagnostic accuracy or clinical outcomes related to a specific disease or condition.
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 perform any of those functions.
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
KGO
Device Description
Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.
COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments.
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
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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 3577-91 and FDA 1000 ml watertight test.
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 results summarized in a table:
| TEST | ASTM D 3577-91 | COMFIT ORTHOPAEDIC Brown Beaded Surgeon's Gloves (Powdered, Hypo) |
|---|
- Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0
- Length (mm) | |
Size 5.5 | min 245 | 260
Size 6.0 | min 265 | 265
Size 6.5 | min 265 | 265
Size 7.0 | min 265 | 270
Size 7.5 | min 265 | 293
Size 8.0 | min 265 | 293
Size 8.5 | min 265 | 293
Size 9.0 | min 265 | 293 - Palm width (mm) | |
Size 5.5 | 70 +/- 6 | 72
Size 6.0 | 76 +/- 6 | 77
Size 6.5 | 83 +/- 6 | 83
Size 7.0 | 89 +/- 6 | 89
Size 7.5 | 95 +/- 6 | 94
Size 8.0 | 102 +/- 6 | 102
Size 8.5 | 108 +/- 6 | 108
Size 9.0 | 114 +/- 6 | 114 - Thickness (mm) | |
Finger | min 0.10 | 0.36
Palm | min 0.10 | 0.31 - Physical Properties | |
Before Ageing: | |
Tensile Strength (MPa) | min 24 | 29.29
Ultimate Elongation (%) | min 750 | 890
After Ageing: | |
Tensile Strength (MPa) | min 18 | 28.38
Ultimate Elongation (%) | min 560 | 852
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, sans-serif font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are enclosed within a rounded, horizontally stretched octagon. The logo is black and white.
APR 2 6 1996
CONTACT PERSON : MR. WEMBLEY RUBBER
(M)
Lot 1, Jalan 3
Kawasan 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 ORTHOPAEDIC,BROWN BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
-
- Common Name : Surgeon Gloves
-
- Classification Name : Surgeon Glove
4. Substantial Equivalence :
Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic , that meets all of the requirements of ASTM standard D3577-91.
5. Description of device :
Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.
COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments.
-
- 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.
- Intended use of device :
1
7. Summary of Performance data :
r
| TEST | ASTM D 3577-91 | COMFIT ORTHOPAEDIC
Brown Beaded Surgeon's
Gloves (Powdered, Hypo) |
|-------------------------|----------------|-------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0 |
| 2. Length (mm) | | |
| Size | | |
| 5.5 | min 245 | 260 |
| 6.0 | min 265 | 265 |
| 6.5 | min 265 | 265 |
| 7.0 | min 265 | 270 |
| 7.5 | min 265 | 293 |
| 8.0 | min 265 | 293 |
| 8.5 | min 265 | 293 |
| 9.0 | min 265 | 293 |
| 3. Palm width (mm) | | |
| Size | | |
| 5.5 | $70 \pm 6$ | 72 |
| 6.0 | $76 \pm 6$ | 77 |
| 6.5 | $83 \pm 6$ | 83 |
| 7.0 | $89 \pm 6$ | 89 |
| 7.5 | $95 \pm 6$ | 94 |
| 8.0 | $102 \pm 6$ | 102 |
| 8.5 | $108 \pm 6$ | 108 |
| 9.0 | $114 \pm 6$ | 114 |
| 4. Thickness (mm) | | |
| Finger | min 0.10 | 0.36 |
| Palm | min 0.10 | 0.31 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 24 | 29.29 |
| Ultimate Elongation (%) | min 750 | 890 |
| After Ageing : | | |
| Tensile Strength (MPa) | min 18 | 28.38 |
| Ultimate Elongation (%) | min 560 | 852 |
Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test.
2
6. 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 3577-91.
7. 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".
8. Conclusion
This glove exceed the ASTM D 3577-91 requirements, meet pinhole FDA requirements , meet Hypoallergenic labeling claim.
Date Summary Prepared : January 20, 1996
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