(195 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device, patient examination gloves, is intended to prevent contamination and provide a barrier, not to treat or alleviate a medical condition.
No
Explanation: The device description states it is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. This indicates it is a barrier device, not a diagnostic one.
No
The device description clearly states it is a "disposable device" made of "natural latex rubber film," indicating it is a physical product, not software.
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 being worn on the hand. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description focuses on the material (natural latex rubber film) and its barrier properties. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, detecting analytes, or providing diagnostic information about a patient's health status.
The device is clearly described as a medical device intended for barrier protection during patient examination.
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 prevent contamination between patient and examiner.
Hypoallergenic patient examination gloves are sultable in situations where healthcare worker or patient allergic sensitivity may be a factor.
Powder free gloves are intended for use in situations where powder should not be used.
Product codes
Not Found
Device Description
Patient examination gloves are made with an intact natural 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
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: Clinical Tests, Non-Clinical Tests
SAMPLE SIZE:
- Modified Draize Repeat Insult Patch Test: 300 human subjects
- Rabbit Skin Irritation: Not Found (Mentioned but no details)
- Guinea Pig Sensitization: Not Found (Mentioned but no details)
KEY RESULTS:
- The specifications for both gloves are identical with respect to water tightness and all physical parameters such as tensile and elongation. Results of testing demonstrate equivalence.
- Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergente.
- There was no evidence of sensitization from the Ultra Care Powder Free Hypoallergenic Latex Patient Examination Gloves on human subjects.
- The proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tasts.
Key Metrics
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
TIL: OTSON HEALTHCARE
| JUL 29 1996 | 510(K) SUBMISSION FOR ULTRA CARE POWDER FREE HYPOALLERGENIC NS PATIENT EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 9, 1996 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996 |
|---|---|
| K960247 510(K) SUMMARY |
| A. INFORMATION | |
|---|---|
| 1. SUBMITTER'S NAME: | TILLOTSON HEALTHCARE CORPORATION |
| ADDRESS: | 360 Route 101 Bedford, NH 03110 U.S.A. |
| TELEPHONE NUMBER: | (603) 472-6600 |
| CONTACT PERSON: | Imogene Tibbetts |
| DATE SUMMARY PREPARED: | December 27, 1995 |
| 2. NAME OF DEVICE | |
| TRADE OR PROPRIETARY NAME: | Ultra Care Powder Free Hypoallergenic Non-Sterile Examination Glove |
| COMMON OR USUAL NAME: | Non-Sterile Powder Free Patient Examination Glove Hypoallergenic |
| CLASSIFICATION NAME: | Patient Examination Glove |
| 3. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER | 1. Formula One Patient Exam Glove K891939 2. Sensi Shield Glove Kit, Inner Glove, K910383 (Hypoallergenic) |
| 4. DESCRIPTION OF DEVICE | Patient examination gloves are made with an intact natural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens, and between patient and examiner. |
| 5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR |
- CONDITIONS THAT THE DEVICE WILL ADDRESS
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
Hypoallergenic patient examination gloves are sultable in situations where healthcare worker or patient allergic sensitivity may be a factor.
Powder free gloves are intended for use in situations where powder should not be used.
-
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE OEVICE
- · The proposed product is identical to the predicate product #1 in the following respects: 1. SPECIFICATIONS, ESPECIALLY WATER TIGHTNESS
- The specifications for both gloves are identical with respect to water tightness and all physical parameters such as tensile and elongation. Results of testing demonstrate equivalence,
-
- FORMULATION OF LATEX
- · The formulation for the latex layer is identical in the proposed and predicate #1 gloves.
- 3. IT IS HYPOALLERGENIC
- · Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergente.
- · The proposed product is different from the predicate product #1 in the following respects:
-
- FORMULATION/PROCESSING METHOD FOR RENDERING GLOVE powder free. The proposed product has an edditional "allp cost" composed of a proprietary polyurethane coating, as a substitute for donning powder.
-
- NO DONNING POWDER Is added.
-
- PROCESSING
-
The proposed product has two extra leach steps in Its process.
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- LABELING; INTENDED USE
The labeling for both products will be substantially the same, including all required label statements. The main differences from predicate #1 are the statements "Powder Free" and "Hypoallergenia".
- LABELING; INTENDED USE
1
510/K) SUBMISSION FOR ULTRA CARE POWDER FREIL HYPOALLERGENIC NS PATIENT EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 9, 1896 SUPPLEMENTAI. SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996
510(K) SUMMARY (oontinued)
- B. IF SE DECISION BASED ON PERFORMANCE DATA 1. DISCUSSION OF NON-CLINICAL TESTS
- SPECIFICATION
PERFORMANCE STANDARDS
WATER TIGHTNESS
- DISCUSSION OF CLINICAL TESTS SPECIFICATION SAFETY RABBIT SKIN IRRITATION
GUINEA PIG SENSITIZATION
MODIFIED DRAIZE REPEAT INSULT PATCH TEST
DESCRIPTION OF SUBJECTS
Image /page/1/Picture/12 description: The image shows two tables, one labeled "PREDICATE" and the other labeled "PROPOSED". The "PREDICATE" table lists "Formula One Patient Examination Glove Hypoallergenic Inner Glove", followed by "ASTM", "ASTM (#1 and #2)", "(#and #2)", and "on 200 human subjects". The "PROPOSED" table lists "Examination Glov". The text in the image is somewhat blurry and difficult to read.
The Modified Draize Repeat Insuit Patch Test, 300 human subjects were used,
DISCU88ION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications
Both the inside surface and the outside surface of Ultra Care Powder Free Hypoallergenic Latex Patient Examination Gioves were evaluated to determine their ability 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 conditions employed in this study, there was no evidence of sensitization
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- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE = / > PREDICATE PRODUCT
The Ultra Care Powder Free Hypoallergenic Exam Glove has been compared to legally marketad devices in the 510(k). The data summarles indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tasts.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE = / > PREDICATE PRODUCT
Pursuant to 21 C.F.R. 807.87 ( ) ), I, Imogene Tibbetts, Director of Medical and Scientific Support Services, certify that to the bast of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Olrector 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 knowlngly omlitted from this submission.
Imogene Talbott
Imogene Tibbetts Director of Medical and Scientific Support Services