(88 days)
Not Found
Not Found
No
The device description and performance data relate to physical properties and material testing of surgical gloves, with no mention of AI or ML.
No
The device is a surgeon's glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
The device description clearly states it is a "natural rubber latex surgeon glove" intended to "prevent contamination". It does not describe any function related to diagnosing medical conditions.
No
The device description clearly identifies the device as 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, which are relevant to its barrier function and comfort, not to any diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing any kind of diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical integrity of the glove (watertightness, strength, elongation) and its hypoallergenic properties, which are relevant to its intended use as a barrier and protective device. They do not involve any diagnostic performance metrics.
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 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
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 MICROPTIC brown surgical gloves are 0.15 mm (minimum) thick single wall to increase finger sensitivity during micro-surgery.
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
Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test.
TEST: Watertight (1000 ml)
ASTM D 3577-91: S-4, AQL 1.5
Comments of Children's Surgeon's Gloves (Powdered Type): Pass based on AQL of 1.0
TEST: Length (mm)
Size 5.5: min 245 (ASTM D 3577-91), 260 (Comments)
Size 6.0: min 265 (ASTM D 3577-91), 265 (Comments)
Size 6.5: min 265 (ASTM D 3577-91), 265 (Comments)
Size 7.0: min 265 (ASTM D 3577-91), 270 (Comments)
Size 7.5: min 265 (ASTM D 3577-91), 298 (Comments)
Size 8.0: min 265 (ASTM D 3577-91), 298 (Comments)
Size 8.5: min 265 (ASTM D 3577-91), 298 (Comments)
Size 9.0: min 265 (ASTM D 3577-91), 298 (Comments)
TEST: Palm width (mm)
Size 5.5: 70 +/- 6 (ASTM D 3577-91), 72 (Comments)
Size 6.0: 76 +/- 6 (ASTM D 3577-91), 77 (Comments)
Size 6.5: 83 +/- 6 (ASTM D 3577-91), 83 (Comments)
Size 7.0: 89 +/- 6 (ASTM D 3577-91), 89 (Comments)
Size 7.5: 95 +/- 6 (ASTM D 3577-91), 95 (Comments)
Size 8.0: 102 +/- 6 (ASTM D 3577-91), 102 (Comments)
Size 8.5: 108 +/- 6 (ASTM D 3577-91), 108 (Comments)
Size 9.0: 114 +/- 6 (ASTM D 3577-91), 114 (Comments)
TEST: Thickness (mm)
Finger: min 0.10 (ASTM D 3577-91), 0.20 (Comments)
Palm: min 0.10 (ASTM D 3577-91), 0.17 (Comments)
TEST: Physical Properties - Before Ageing
Tensile Strength (MPa): min 24 (ASTM D 3577-91), 24.97 (Comments)
Ultimate Elongation (%): min 750 (ASTM D 3577-91), 862 (Comments)
TEST: Physical Properties - After Ageing
Tensile Strength (MPa): min 18 (ASTM D 3577-91), 19.66 (Comments)
Ultimate Elongation (%): min 560 (ASTM D 3577-91), 863 (Comments)
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
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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, 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, oval-shaped border. The background is white.
CONTACT
I of 1 Ja san Perusahaan Bandar B Selek Tinggi 43900 Sepana Carporate Office Tel: 8461486 8481867 8461485 8461557 8481499 Factory Office RAR1496 Frx: 8461488 3461808
510 (K) SUMMARY
: COMFIT MICROPTIC,BROWN BEADED 1. Trade Name SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
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Common Name : Surgeon Gloves
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Classification Name : Surgeon Glove
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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.
- 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 MICROPTIC brown surgical gloves are 0.15 mm (minimum) thick single wall to increase finger sensitivity during micro-surgery.
- 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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7. Summary of Performance data :
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Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3577-91 | Comments of Children's Surgeon's Gloves
(Powdered Type) |
|-------------------------|----------------|------------------------------------------------------------|
| 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 | 298 |
| 8.0 | min 265 | 298 |
| 8.5 | min 265 | 298 |
| 9.0 | min 265 | 298 |
| 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 | $95 \pm 6$ | 95 |
| 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 | 0.20 |
| Palm | min 0.10 | 0.17 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 24 | 24.97 |
| Ultimate Elongation (%) | min 750 | 862 |
| After Ageing : | | |
| Tensile Strength (MPa) | min 18 | 19.66 |
| Ultimate Elongation (%) | min 560 | 863 |
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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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