(194 days)
Not Found
No
The summary describes a standard patient examination glove and does not mention any AI or ML capabilities.
No.
The device acts as a barrier to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device is a patient examination glove, intended as a barrier to prevent contamination. It does not gather information about a patient's health condition or make a determination about a diagnosis.
No
The device description clearly states it is a physical glove made of natural latex rubber film, which is a hardware component.
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 patient and examiner by providing a barrier. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the material (latex rubber film) and its barrier properties. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, body fluids, tissues, or any other biological samples to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance study described is a patch test for sensitization, which relates to the safety of the glove material when in contact with skin, not its ability to diagnose anything.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a barrier product for infection control.
N/A
Intended Use / Indications for Use
"This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to provent contamination between patient and examiner. Gloves with labeled protein are sultable In situations where health care worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity."
Product codes
Not Found
Device Description
"Patient examination gloves are made with intect netural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"examiner"
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: Modified Draize Repeat Insult Patch Test
Sample Size: 300 human subjects
Key Results: "Under the contions employed in this study, there was no evidence of sensitization." for the proposed product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 29 1996
ID:6034710265
51QK) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTENT) NO EXAM GLOVE
ORIGINAL SUBMISSION DATE: JANUARY 16, 1996 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996
510(K) SUMMARY
360 Route 101
(603) 472-8600
Imogene Tibbetts
July 26, 1996
Bedford, NH 03110 USA
- INFORMATION (A)
-
- SUBMITTER'S NAME
ADDRESS
TELEPHONE NUMBER
CONTACT PERSON
DATE SUMMARY PREPARED
- NAME OF DEVICE 2. TRADE OR PROPRIETARY NAME
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) Non-Sterile Patient Examination Glove
TILLOTSON HEALTHCARE CORPORATION
COMMON OR USUAL NAME Non-Sterile Powder Free Patient Examination Glove
Patient Examination Glove
CLASSIFICATION NAME
- PREDICATE DEVICE IDENTIFICATION 3. NAME, NUMBER
-
- Powder Free Plus Patient Exam Glove (WITH LABELED PROTEIN CONTENT). K954855, SE 12/28/95
- CUT RESISTANT GLOVE KIT 2. WITH HYPOALLERGENIC INNER GLOVE #K910383
- ব . DESCRIPTION OF DEVICE Patient examination gloves are made with intect netural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner.
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS ર્ડ THAT THE DEVICE WILL ADDRESS
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to provent contamination between patient and examiner. Gloves with labeled protein are sultable In situations where health care worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity.
1
510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) NS EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 18, 1998 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1998 REVISION DATE: JULY 26, 1996
EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE છે.
1. SIMILARITIES
Proposed and Prodicate #1
- The proposed product is physically identical to the predicate #1 in all respects. .
- It is powder free, in the same way as its predicate #1. . Both predicate #1 and proposed will be labeled with protein content.
- . The processing of the Proposed product Is Identical to Product #1.
| PREDICATE | PROPOSED |
|---|---|
| POWDER FREE PLUS | |
| (WITH LABELED PROTEIN CONTENT) | |
| (#K954855 details on file) | POWDER FREE PLUS |
| HYPOALLERGENIC (WITH LABELED | |
| PROTEIN CONTENT) | |
| 5 step washing/leaching process. | 5 step washing/leaching process. |
Proposed & Predicate #2
- . Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergenic.
- They are both labeled "Hypoallergenic". .
2. DIFFERENCES - LABELING: INTENDED USE
Proposed and Predicate #1
The labeling for both products will be the same, including all required label statements.
The difference is the statement, "Hypoallergenic" for the proposed.
The proposed product is sultable in situations where health care worker or patient allergic sensitivity may be a factor.
2
510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) NS EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 16, 1996 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1986 REVISION DATE: JULY 26, 1996
IF THE SE DECISION IS BASED ON PERFORMANCE DATA (B)
DISCUSSION OF NON-CLINICAL TESTS 1.
| PHYSICAL DIMENSIONS | ASTM (Passes) | ASTM (Passes) |
|---|---|---|
| PHYSICAL PROPERTIES | ASTM (Passes) | ASTM (Passes) |
| WATER TIGHTNESS | ASTM (Passes) | ASTM (Passes) |
2. DISCUSSION OF PRE-CLINICAL TESTS
| SPECIFICATION | PREDICATE | PROPOSED |
|---|---|---|
| SAFETY | ||
| RABBIT SKIN IRRITATION | Passes ( #'s 1 and 2 ) | Passes |
| GUINEA PIG SENSITISATION | Passes ( #'s 1 and 2 ) | Passes |
3. DISCUSSION OF CLINICAL TESTS
| SPECIFICATION | PREDICATE | PROPOSED |
|---|---|---|
| MODIFIED DRAIZE REPEAT | ||
| INSULT PATCH TEST ON | ||
| 200 (300) HUMAN SUBJECTS | ||
| Predicate #2 | Passed (# 2 ) | |
| Predicate Product: Glove Kit, etc. | ||
| 200 Human Subjects | Passes | |
| Proposed Product: Hypoallergenic | ||
| 300 Human Subjects |
DESCRIPTION OF SUBJECTS
For the Modified Draize Repeat Insult Patch Test, 300 human subjects were used.
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications
Both the inside surface and the outside surface of POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) LATEX PATIENT EXAMINATION GLOVES were evaluated to determine their ablity to sensitize the skin of normal volunteer subjects using occlusive repeated insuit patch study. About three hundred persons at three different locations completed the study. Under the contions employed in this study, there was no evidence of sensitization.
3
510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (MITH LABELED PROTEIN CONTENT) NS EXAM QLOVE ORIGINAL SUBMISSION DATE: JANUARY 18, 1998 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996
CONCLUSIONS DRAWN FROM NON-CLINICAL, PRE-CLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY, EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The POWDER FREE PLUS HYPOALLERGENIC LATEX EXAM GLOVE (WITH LABELED PROTEIN CONTENT) has been compared to legally marketed devices in the 510(k). The data summaries Indicate that the proposed product meets accessfor the predicate products in physical, non-cilnical and clinical tests.
Pursuant to 21 C.F.R. 807.87 ( ) }, I Imogene Tibbetts, Director of Medical and Scientlific Support Services, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Director of Medical and Scientific Support Services for TILLOTSON HEALTHCARE CORPORATION, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly ornitted from this submission.
Lorene Tibbetts
Imogene Tibbetts Director of Medical and Scientific Support Services