(195 days)
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.
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.
The provided text describes a 510(k) submission for the "Ultra Care Powder Free Hypoallergenic Non-Sterile Patient Exam Glove." This is a medical device, and the submission focuses on demonstrating its substantial equivalence to predicate devices, rather than a typical clinical study proving disease-related performance.
Therefore, the requested information elements (especially those related to "AI," "radiologist," "MRMC," "training set," "adjudication," "effect size," and "outcomes data") are not applicable to this type of device submission. The acceptance criteria and "study" described here pertain to the physical properties, safety, and hypoallergenic nature of a glove, not a diagnostic or therapeutic AI-driven device.
Here's an adaptation of the requested information based on the provided text, focusing on the relevant aspects for this medical device submission:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily based on demonstrating equivalence to predicate devices for physical properties and safety.
| Feature | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Ultra Care Powder Free Hypoallergenic NS Patient Exam Glove) |
|---|---|---|
| Physical Properties | ||
| Water Tightness | Identical specifications to Predicate Product #1 (Formula One Patient Exam Glove K891939). Results of testing must demonstrate equivalence. Adherence to ASTM standards where applicable. | "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." (Section A.6) |
| Tensile Strength | Identical specifications to Predicate Product #1. Results of testing must demonstrate equivalence. | "..."parameters such as tensile and elongation. Results of testing demonstrate equivalence." (Section A.6) |
| Elongation | Identical specifications to Predicate Product #1. Results of testing must demonstrate equivalence. | "..."parameters such as tensile and elongation. Results of testing demonstrate equivalence." (Section A.6) |
| Formulation | ||
| Latex Formulation | Identical formulation for the latex layer as Predicate Product #1. | "The formulation for the latex layer is identical in the proposed and predicate #1 gloves." (Section A.6) |
| Safety & Biocompatibility | ||
| Hypoallergenic | Must pass a Modified Draize Repeat Insult Patch Test on human subjects, demonstrating a lack of sensitization, similar to Predicate Product #2 (Sensi Shield Glove Kit, Inner Glove, K910383). | "Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergenic." (Section A.6). "Under the conditions employed in this study, there was no evidence of sensitization" (Section B.2). |
| Rabbit Skin Irritation | Must meet acceptable scores/standards for safety, similar to predicate products. Standard biological evaluation criteria for medical devices. | The summary states, "The data summaries indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tests." (Section B.3) |
| Guinea Pig Sensitization | Must meet acceptable scores/standards for safety, similar to predicate products. Standard biological evaluation criteria for medical devices. | The summary states, "The data summaries indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tests." (Section B.3) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Hypoallergenic Test (Modified Draize Repeat Insult Patch Test):
- Sample Size: 300 human subjects.
- Data Provenance: Retrospective, from "three different locations" (implied US-based, as this is a US regulatory submission).
-
Physical Property Tests (Water Tightness, Tensile, Elongation):
- Sample Size: Not explicitly stated for the "results of testing," but samples would have been drawn from manufacturing lots.
- Data Provenance: Retrospective, from internal product testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Hypoallergenic Test: The "Modified Draize Repeat Insult Patch Test" involves clinical evaluation by medical professionals (e.g., dermatologists or clinicians specializing in allergy/irritation). The specific number and qualifications of the conducting/evaluating experts are not provided, but it's implied to be a standard clinical test procedure.
- Physical Property Tests: Ground truth is established by standardized test methods (e.g., ASTM standards) and direct measurement, not expert consensus.
4. Adjudication Method for the Test Set
- Hypoallergenic Test: No explicit adjudication method (like 2+1) is described for the human subject patch test. The "no evidence of sensitization" conclusion implies a direct observation by the clinical evaluators.
- Physical Property Tests: Not applicable, as it involves direct measurement against specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not applicable for a patient examination glove. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in the sense that the device itself was tested directly. The tests for water tightness, tensile strength, elongation, and the Modified Draize Repeat Insult Patch Test directly evaluated the glove's performance as a standalone product. There is no "algorithm" or human-in-the-loop component for this device.
7. The Type of Ground Truth Used
- Physical Properties: Objective measurements against pre-defined specifications and ASTM standards.
- Hypoallergenic Test: Clinical observation and evaluation by medical professionals in a controlled human subject test, demonstrating the absence of sensitization (a form of clinical ground truth).
- Safety (Rabbit Skin Irritation, Guinea Pig Sensitization): Biological test results against established safety criteria.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "training set." The product's manufacturing process and formulation are established, and subsequent testing (as described above) confirms the final product characteristics.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, this question does not apply. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and regulatory standards for medical gloves.
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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.
-
- 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
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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
-
- 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
§ 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.