(199 days)
K932404 (Safeskin)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a nitrile glove, with no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between healthcare personnel and patients/their environment, not to treat or diagnose a disease or condition.
No
This device is a patient examination glove intended to prevent contamination, not to diagnose a medical condition or disease.
No
The device is a physical glove made of nitrile, not a software application.
Based on the provided information, 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 the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The device is a patient examination glove. Its description focuses on physical properties, material composition, and compliance with standards related to gloves. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The performance studies described (dimensional and physical properties, powder-free assessment, biocompatibility) are relevant to the safety and performance of a barrier device like a glove, not an IVD.
N/A
Intended Use / Indications for Use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Product codes (comma separated list FDA assigned to the subject device)
80 EMC
Device Description
This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.
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 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)
- Study Type: Non-clinical performance data and Clinical Performance Data
- Non-clinical performance data:
- Dimensional and Physical Properties: Both gloves comply with ASTM 3578-91 Standard and the FDA Water Leak Test.
- Powder-free Assessment:
- Residue weight:
§ 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
DEC 1 9 1996
Safeskin Corporation Submitted: May 28, 1996 Contact: Michelle Molloy 12671 High Bluff Drive San Diego, California 92130 Phone: (619) 784-8111 Fax: (619) 350-2380
Attachment 8 510(k) Summary of Safety and Effectiveness
1
Image /page/1/Picture/0 description: The image shows the logo for SAFESKIN. The logo consists of a circle with two curved lines inside, resembling an "S". Below the circle, the word "SAFESKIN" is written in bold, sans-serif font. There is a trademark symbol to the right of the word SAFESKIN.
Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130 Tel: (800) 462-9993 (619) 784-8111 Fax: (619) 350-2380
Hypoallergenic Powder-Free Nitrile Examination Gloves
510 (K) SUMMARY of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
-
- [807.92(c)] Separate Document
**
- [807.92(c)] Separate Document
| 2. [807.92(a)] Applicant: | Safeskin Corporation
12671 High Bluff Drive
San Diego, California 92130
Phone: (619) 784-8111
Fax: (619) 350-2380 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michelle Molloy
Safeskin Corporation
12671 High Bluff Drive
San Diego, California 92130
Phone: (619) 784-8111
Fax: (619) 350-2380 |
| 3. [CFR 880.6250] | Date Summary Prepared: May 28, 1996
Name of Device:
Proprietary Name: Safeskin
Common Name: Nitrile exam gloves
Classification: Patient examination glove (per 21CFR 880.6250) |
| 4. [807.92 (a)(3)] | Equivalence: The legally marketed device to which equivalence is claimed is K932404 (Safeskin) a Class 1 Nitrile patient examination glove 80 EMC |
2
5. [807.92(a)(4)]
Description:
This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.
| Same | Different | |
|---|---|---|
| Formulation | ✓ | |
| Processing | ✓ | |
| Powder-Free | ✓ | |
| Non-Sterile | ✓ | |
| Biocompatibility | ✓ | |
| Physical Testing | ✓ | |
| Hypoallergenic | ✓ | |
| Colorant | ✓ |
Similarity and Differences Comparison Between Safeskin's K932404 and This New Submission
-
Intended Use: 6. [807.92(a)(5)] A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. 7. [807.92(a)(6)] Technological Characteristics of applicant device compared to predicate device; non-clinical performance data: Both gloves comply with ASTM 3578-91 Standard and the FDA Water
Leak Test. -
Gloves comply with ASTM D3578-91 and FDA. 1,000 mL Water Leak requirement. A.
-
The powder-free assessment which follows is based upon the procedure: B.
3
Tests for Particulates by Weight and lodine Color as described on pg. 5.54 in Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA, May 1993.
| B. Powder-free Assessment | COMPARISON | ||
|---|---|---|---|
| K932404 | Applicant Device | ||
| Residue weight | $\leq$ 2 mg | same glove | same glove |
| Results of iodine assay (cornstarch) | ASTM Standard F 720-81 | ||
| (Reapproved in 1986) | Pass | Pass | |
| • | 200 Person Modified Draize Test | ||
| DSMA Regulatory Requirements | |||
| for Medical Gloves, May 1993. | Not tested | Pass |
Non-clinical performance data: 8. [807.92(a)(c)]
A summary of results of non-clinical performance evaluations is presented above. A brief description of these tests follows:
A: Dimensional and Physical Properties.
ASTM D3578-91 specifies the dimensional measurement requirements including thickness to which the Applicant and K932404 gloves comply, unless otherwise noted.
1,000 mL FDA Water Leak Test consists of attaching a glove over the end of a plastic cylinder and dispensing 1,000 mL of water into the glove. Leaks within a two-minute period are recorded as failures. Testing is performed according to 21CFR 800.20 (b)(1). Sampling is performed utilizing Mil Std. 105E or an increased sampling tightness when deemed appropriate. Applicant glove and K932404 meet this FDA requirement.
4
B: The powder-free test method is an assay, described as recommendations in the Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA May, 1993. A water extract of the gloves is filtered, dried and the residue weighed to determine the total particulate removed from the glove. K932404 demonstrate Applicant glove and verv low particulate/cornstarch levels; however, no standards have been set by the FDA or the ASTM.
C: Biocompatibility.
Primary Dermal Irritation. The testing is performed according to the regulations of the Consumer Product Safety Commission, Title 16, Chapter II, Part 1500. The purpose of the study is to determine the dermal irritation potential of the glove to the shaved intact and abraded skin on the backs of albino rabbits. Appropriate controls were conducted. Applicant glove showed no significant irritancy potential.
Dermal Sensitization (Buehler) Study. This study is performed on fifteen young adult Hartley Guinea Pigs (male) per extract to determine the sensitization potential of the gloves. Safeskin Powder-Free Nitrile Exam Gloves were tested with Dinitrochlorobenzene (DCNB) used for a positive control substance. A one inch square patch of test material was applied to clipped areas of the test animals, once weekly for three weeks, six hours per exposure. Erythema and edema were scored according to Draize evaluation. The Challenge phase was conducted two weeks after the last administration of induction dose in the same manner as previously described. Appropriate controls were conducted. Applicant glove showed no significant sensitization potential.
9. [807.92(b)(2)] Clinical Performance Data:
The 200 person Modified Draize Test was performed on the applicant glove to comply with FDA requirements for obtaining the Hypoallergenic claim. This test was conducted to determine by epidermal contact the primary or cumulative irritation and/or sensitization potential of the test material. Test site was the upper back between the scapulae. Test sample portions of the glove were attached to the back. This procedure was followed three times per week for a total of ten applications. Observations and scoring were made at each test period. Following a two-week rest period, two consecutive challenge patches of the test material were applied to a different site on the scapular back under occlusive patches.
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| 10. [807.92 (b)(3)] | Conclusions drawn from the non-clinical and clinical tests in 7, 8,
and 9 above:
The applicant glove meets or exceeds ASTM standards, FDA pinhole
requirements and labeling claims as demonstrated in 7, 8, and 9 above. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. [807.92 (d)] | Other information deemed necessary by the FDA. |
- [807.92 (d)] No other information has been requested at this time.
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