(111 days)
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Not Found
No
The device description and performance studies focus on the physical properties and hypoallergenic nature of the gloves, with no mention of AI or ML.
No
The device, a surgical glove, is intended to prevent contamination between healthcare personnel and the patient. It does not exert any therapeutic effect on the patient or the user.
No
The device is a surgeon's glove, used to prevent contamination, not to diagnose a condition.
No
The device description clearly states it is a physical glove made of natural rubber latex, which is a hardware component. There is no mention of software as the primary or sole component.
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 surgical glove made of latex, meeting specific ASTM standards for physical properties and performance as a barrier. There is no mention of any components or functions related to analyzing samples or providing diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical properties of the glove (watertight test) and its hypoallergenic properties, which are relevant to its barrier and safety function, not its diagnostic capability.
Therefore, based on the provided information, this device is a medical device intended for barrier protection, not an in vitro diagnostic device.
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)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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. The performance test data indicate that this glove meets requirements of ASTM D 3577-91. Clinical data of 200 Human Modified Draize test done on this glove demonstrated no potential for eliciting either dermal irritation or sensitization and support the labeling claim for "hypoallergenic". This glove exceed the ASTM D 3577-91 requirements, meet pinhole FDA requirements, meet Hypoallergenic labeling claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Watertight (1000 ml): Pass based on AQL of 1.0 (ASTM D 3577-91: S-4, AQL 1.5)
Length (mm):
Size 5.5: 260 (min 245)
Size 6.0: 265 (min 265)
Size 6.5: 265 (min 265)
Size 7.0: 270 (min 265)
Size 7.5: 302 (min 265)
Size 8.0: 302 (min 265)
Size 8.5: 302 (min 265)
Size 9.0: 302 (min 265)
Palm width (mm):
Size 5.5: 72 (70 +- 6)
Size 6.0: 77 (76 +- 6)
Size 6.5: 83 (83 +- 6)
Size 7.0: 89 (89 +- 6)
Size 7.5: 96 (95 +- 6)
Size 8.0: 102 (102 +- 6)
Size 8.5: 108 (108 +- 6)
Size 9.0: 114 (114 +- 6)
Thickness (mm):
Finger: 0.25 (min 0.10)
Palm: 0.21 (min 0.10)
Physical Properties:
Before Ageing:
Tensile Strength (MPa): 26.0 (min 24)
Ultimate Elongation (%): 855 (min 750)
After Ageing:
Tensile Strength (MPa): 23.4 (min 18)
Ultimate Elongation (%): 890 (min 560)
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
§ 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/0 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are enclosed within a thick, black-lined, rounded, and irregular polygon shape. The logo has a simple, clean design and is presented in black and white.
| K96078 |
|---|
| -------- |
510 (K) SUMMARY
l. Trade Name
: COMFIT BROWN,BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENI
CONTACT PERSON
-
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.
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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7. Summary of Performance data :
| TEST | ASTM D 3577-91 | COMFIT 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 | 302 |
| 8.0 | min 265 | 302 |
| 8.5 | min 265 | 302 |
| 9.0 | min 265 | 302 |
| 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 | $95 \pm 6$ | 96 |
| 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 | 0.25 |
| Palm | min 0.10 | 0.21 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 24 | 26.0 |
| Ultimate Elongation (%) | min 750 | 855 |
| After Ageing: | | |
| Tensile Strength (MPa) | min 18 | 23.4 |
| Ultimate Elongation (%) | min 560 | 890 |
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 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 06, 1996
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