(150 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free." It details the device's technical characteristics, non-clinical performance, and comparison to a predicate device to demonstrate substantial equivalence.
This document describes the testing of a medical device (examination gloves), which
Does not involve AI, machine learning, or complex algorithmic performance in its functionality or assessment. The tests performed are
physical, chemical, and biological compatibility tests of the material itself.
Therefore, the requested information regarding acceptance criteria and study proving AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document. The document describes the data and testing for a Class I medical device (gloves) and demonstrates its "substantial equivalence" to an existing predicate device, primarily through non-clinical bench testing and biocompatibility studies.
However, I can extract the acceptance criteria and reported performance for the physical and biological properties of the gloves, as provided in the document.
Acceptance Criteria and Reported Device Performance for Blue Nitrile Examination Gloves Powder Free
Since this is a physical medical device (gloves) and not an AI/ML-driven device, the criteria typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity for a diagnostic algorithm) are not relevant here. Instead, the acceptance criteria relate to the physical properties, chemical composition, and biocompatibility of the gloves, demonstrating they meet established standards for medical examination gloves.
Here's the table of acceptance criteria and reported device performance based on the non-clinical testing summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Physical Properties | ||||
| Length | ASTM D6319-10 (Reapproved 2015) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 404 mmSmall: 404 mmMedium: 405 mmLarge: 404 mmX-Large: 404 mm |
| Width | ASTM D6319-10 (Reapproved 2015) | To determine the width of the gloves | X-small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10 mmLarge: 110+/-10 mmX-Large: 120+/-10 mm | X-small: 74 mmSmall: 84 mmMedium: 94 mmLarge: 105 mmX-Large: 115 mm |
| Thickness | ASTM D6319-10 (Reapproved 2015) | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | Palm:X-Small: 0.20mmSmall: 0.19mmMedium: 0.20mmLarge: 0.20mmX-Large: 0.20mmFinger:X-Small: 0.22mmSmall: 0.21mmMedium: 0.22mmLarge: 0.21mmX-Large: 0.22mm |
| Tensile Strength | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 14Mpa Min for all sizesAfter Ageing: 14Mpa Min for all sizes | Before Ageing:X-Small: 22.0MpaSmall: 23.0MpaMedium: 25.6MpaLarge: 24.0MpaX-Large: 24.5MpaAfter Ageing:X-Small: 18.5MpaSmall: 20.5MpaMedium: 22.0MpaLarge: 21.0MpaX-Large: 21.7Mpa |
| Ultimate Elongation | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 500% Min for all sizesAfter Ageing: 400% Min for all sizes | Before Ageing:X-Small: 898%Small: 896%Medium: 868%Large: 899%X-Large: 874%After Ageing:X-Small: 872%Small: 861%Medium: 828%Large: 869%X-Large: 853% |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | To determine the holes in the gloves | AQL 2.5 | Gloves pass AQL 1.5 (This meets or exceeds the AQL 2.5 criteria, as a lower AQL indicates fewer allowable defects). |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | 2 mg/glove Max | X-small: 0.16 mg/gloveSmall: 0.20 mg/gloveMedium: 0.21 mg/gloveLarge: 0.20 mg/gloveX-Large: 0.21 mg/glove |
| Biocompatibility | - | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | To determine the potential to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | To determine skin sensitization potential in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009(E) | To evaluate in vitro cytotoxic potential in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. (This indicates an initial result that was followed up to ensure safety). |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | To determine acute systemic toxicity potential in swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. (This addresses the concern from the cytotoxicity test). |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41 <151> | To determine pyrogenic potential in New Zealand white Rabbits | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Since the device is a simple medical examination glove and not an AI/ML system, the following points regarding AI/ML study design are explicitly not applicable to the data provided in this document:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical and chemical tests on manufactured gloves, not a "test set" of patient data for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by adherence to physical standards (ASTM) and biological safety (ISO, USP), not expert annotation of medical images/data.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for performance assessment of diagnostic/AI tools with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is compliance with established international standards for physical properties and biocompatibility of medical gloves.
- The sample size for the training set: Not applicable. There is no training set as there is no AI/ML model.
- How the ground truth for the training set was established: Not applicable.
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January 24, 2020
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K192333
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: December 11, 2019 Received: December 16, 2019
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192333
Device Name
Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
510K SUMMARY as required by: 21CFR § 807.92(c) K192333
A. APPLICANT INFORMATION
| 510(k) Owner's Name | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---|---|
| Address | Lot 8 & 10, Jalan Zurah 3, Lot 1 & 3, Jalan Zurah, 3A/1,Pusat Perindustrian 2, 44200 Rasa, Selangor DarulEhsan, Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| ganeshjrmt@gmail.com | |
| Contact Person | Mr.Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | 5th Aug 2019 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. Predicate Device
| Predicate Device | MCare Blue Nitrile Examination GlovesPowder-free |
|---|---|
| 510( k) Number | K172930 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THE DEVICE:
JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
E.INTENDED USE OF THE DEVICE:
JR MEDIC Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Remarks | |
|---|---|---|---|---|
| PREDICATE | SUBJECT | |||
| 510(k) Number | K172930 | K192333 | ---- | |
| Name of device | MCare Blue NitrileExamination GlovesPowder Free | JR MEDIC BlueNitrile ExaminationGloves Powder Free | ---- | |
| Dimensions | ASTMD6319-10(Reapproved 2015) | Length Min 230 mWidth Min 95+/-10mm(for mediumsize) | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Same |
| Physical Properties | ASTMD6319-10(Reapproved 2015) | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Same |
| Thickness | ASTMD6319-10(Reapproved 2015) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Free | ASTMD6319-10 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the conditionof study not anirritant | Under the conditionof study not anirritant | Same |
| Dermal Sensitization-ISO 10993-10:2010(E) | Under the conditionsof the study not asensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5 :2009(E) | Data Not available | Under the conditionsof the study,cytotoxic.Additional testingwas performed todetermine if this wasa systemic toxicityconcern | ---- |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
| POWDER FREE | |||
|---|---|---|---|
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Data Not available | Under the conditionof study the deviceextracts do not pose asystemic toxicityconcern | ----- |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | Data Not available | Under the conditionsof the study, thedevice did notdemonstrate amaterial mediatedpyrogenicityresponse. | ----- |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Remarks | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| Water Tight (1000 ml) | ASTM D5151-06 | Passes | Passes AQL-2.5 | Similar |
| Intended use | MCare Blue NitrileExaminationGlovesPowderfree is disposabledevicesintendedformedicalpurpose that arewon ontheexaminer's hand topreventcontaminationbetweenpatientand examiner. | JR MEDIC Blue NitrileExaminationGlovesPowder Free is disposabledevices intendedformedical purpose that arewon on the examiner'shand topreventcontaminationbetweenpatient and examiner. | Similar | |
| Material | ASTMD6910-10(Reapproved2015) | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-10(Reapproved2015) | Extra Small, Small,Medium, Large,Extra Large | Extra Small, Small,Medium, Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | Mercator Medical(Thailand) LTD | JR Engineering &Medical Technologies(M) SDN.BHD.Malaysia | ----- |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6913-10.
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
G. Non-Clinical Testing Summary
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To determine thelength of the gloves | Min 230 mm for all sizes | X-Small:-404 mmSmall:-404 mmMedium:-405 mmLarge:-404 mmX-Large:-404 mm |
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To determine thewidth of the gloves | X-small:- 70+/-10 mmSmall:-80+/-10 mmMedium:-95+/-10 mmLarge:-110+/-10 mmX-Large:-120+/-10 mm | X-small:-74 mmSmall:-84 mmMedium:-94 mmLarge:-105 mmX-Large:-115 mm |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | Size Palm FingerX-Small 0.20mm 0.22mmSmall 0.19mm 0.21mmMedium 0.20mm 0.22mmLarge 0.20mm 0.21mmX-Large 0.20mm 0.22mm |
| To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | Size Before Afterageing ageingX-Small 22.0Mpa 18.5MpaSmall 23.0Mpa 20.5MpaMedium 25.6Mpa 22.0 MpaLarge 24.0Mpa 21.0MpaX-Large 24.5Mpa 21.7Mpa | |
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for allsizesAfter AgeingUltimateElongation 400%Min for all sizes | Size Before Afterageing ageingX-Small 898% 872%Small 896% 861%Medium 868% 828%Large 899% 869%X-Large 874% 853% |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D5151-06 (Reapproved2015) Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder in thegloves | 2 Mg/Glove Max | SizeX-small 0.16 mg/gloveSmall 0.20 mg/gloveMedium 0.21 mg/gloveLarge 0.20 mg/gloveX-Large 0.21 mg/glove |
BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extractsin L-929mouse fibroblasts cells usingelution method. | Under theconditions of studynon cytotoxic | Under the conditions ofthe study, cytotoxic.Additional testing wasperformed to determineif this was a systemictoxicity concern. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inswiss Albino mice. | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| USP 41<151> Pyrogen Test. | To determine the pyrogenicpotential of the test itemextract following intravenousinjection in New Zealandwhite Rabbits. | Under theconditions of thestudy, the devicedid notdemonstrate amaterial mediatedpyrogenicityresponse. | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. |
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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE
H. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
I. CONCLUSION
The conclusions drawn from the nonclinical test demonstrate that the subject device in 510(K) submission K192333, Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172930.
§ 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.