← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K960247 # ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE (K960247) _Tillotson Healthcare Corp. · LYY · Jul 29, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960247 ## Device Facts - **Applicant:** Tillotson Healthcare Corp. - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Jul 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## 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 suitable 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. ## Device Story Disposable natural latex rubber examination glove; provides barrier between patient and examiner to prevent cross-contamination. Features proprietary polyurethane 'slip coat' to eliminate need for donning powder; includes two additional leaching steps during manufacturing to reduce potential allergens. Used in clinical settings by healthcare professionals. Hypoallergenic status confirmed via Modified Draize Repeat Insult Patch Test. Benefits include reduced risk of powder-related complications and allergic reactions for sensitive users. ## Clinical Evidence Clinical safety evaluated via Modified Draize Repeat Insult Patch Test on 300 human subjects. Study assessed skin sensitization potential of both inner and outer glove surfaces. Results showed no evidence of sensitization under study conditions. ## Technological Characteristics Natural latex rubber film; polyurethane slip coat; powder-free. Meets ASTM standards for water tightness, tensile strength, and elongation. Manufacturing process includes two additional leaching steps compared to standard latex gloves. ## Regulatory 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. ## Predicate Devices - Formula One Patient Exam Glove ([K891939](/device/K891939.md)) - Sensi Shield Glove Kit, Inner Glove ([K910383](/device/K910383.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} TIL:OTSON HEALTHCARE ID:6034710265 JUL 26'96 12:32 No.004 P.04 JUL 29 1996 510(K) SUMMARY K960247 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 suitable 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. 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE - 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. 2. 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 hypoallergenic. - The proposed product is different from the predicate product #1 in the following respects: 1. FORMULATION/PROCESSING - METHOD FOR RENDERING GLOVE powder free. The proposed product has an additional "slip coat" composed of a proprietary polyurethane coating, as a substitute for donning powder. 2. NO DONNING POWDER is added. 3. PROCESSING The proposed product has two extra leach steps in its process. 4. 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 "Hypoallergenic". Section P (revision) - 510(K) SUMMARY C:\MSOFFICE\EXCEL\DATA\510K\510K39.XLS {1} TILLOTSON HEALTHCARE ID:6034710265 JUL 26'96 12:33 No.004 P.05 510(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 510(K) SUMMARY (continued) B. IF SE DECISION BASED ON PERFORMANCE DATA 1. DISCUSSION OF NON-CLINICAL TESTS SPECIFICATION | PREDICTIVE | PROPOSED | | --- | --- | | 1. Formula One Patient Examination Glove | Ultra Care Powder Free Hypoallergenic Patient Examination Glove | | 2. Renal Shield Glove Kit Hypoallergenic Inner Glove | ASTM | | ASTM ( #1 ) | ASTM | | ASTM ( #1 and #2 ) | ASTM | | PERFORMANCE STANDARDS | | | WATER TIGHTNESS | | | Passes ( #1 and #2 ) | Passes | | Passes ( #1 and #2 ) | Passes | | on 200 human subjects | on 300 human subjects | 2. DISCUSSION OF CLINICAL TESTS SPECIFICATION SAFETY RABBIT SKIN IRRITATION GUINEA PIG SENSITIZATION MODIFIED DRAIZE REPEAT INSULT PATCH TEST DESCRIPTION OF SUBJECTS 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 Ultra Care Powder Free Hypoallergenic Latex Patient Examination Gloves were evaluated to determine their ability to sensitize the skin of normal volunteer subjects using occlusive repeated insult 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 3. 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 marketed devices in the 510(k). The data summaries indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tests. Pursuant to 21 C.F.R. 807.87 ( ), Imogene Tibbetts, Director of Medical and Scientific 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 omitted from this submission. Imogene Tibbetts Director of Medical and Scientific Support Services PAGE 2 OF 2 Section P (revision) - 510(K) SUMMARY C:\MSOFF\CREXCEL\DATA\510K\510K39.XLS --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960247](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960247) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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