(455 days)
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.
Here's the information based on the provided text, focusing on the non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties (Before Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 18.0 MPa | XS: 24.40 MPa, S: 24.56 MPa, M: 27.18 MPa, L: 26.51 MPa, XL: 26.11 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 650% | XS: 792 %, S: 808 %, M: 817 %, L: 811 %, XL: 783 % | Pass |
| Stress at 500% Elongation | ASTM D412 | Max. 5.5 MPa | XS: 4.77 MPa, S: 5.11 MPa, M: 4.55 MPa, L: 4.85 MPa, XL: 5.22 MPa | Pass |
| Physical Properties (After Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 14.0 MPa | XS: 25.59 MPa, S: 22.37 MPa, M: 27.16 MPa, L: 25.95 MPa, XL: 26.67 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 500% | XS: 802 %, S: 723 %, M: 809 %, L: 829 %, XL: 785 % | Pass |
| Dimension | ASTM D3767 (Rubber Measurement of Dimensions) | |||
| Length | ASTM D3767 | Min 240 mm (for all sizes) | XS: 243 mm, S: 243 mm, M: 243 mm, L: 243 mm, XL: 243 mm | Pass |
| Width | ASTM D3767 | XS: Max 80 mm, S: Min 80 ± 10 mm, M: Min 95 ± 10 mm, L: Min 110 ± 10 mm, XL: Min 110 mm | XS: 78 mm, S: 84 mm, M: 95 mm, L: 106 mm, XL: 116 mm | Pass |
| Thickness (Finger) | ASTM D3767 | Min 0.11 mm | XS: 0.14 mm, S: 0.14 mm, M: 0.15 mm, L: 0.15 mm, XL: 0.16 mm | Pass |
| Thickness (Palm) | ASTM D3767 | Min 0.09 mm | XS: 0.12 mm, S: 0.12 mm, M: 0.12 mm, L: 0.12 mm, XL: 0.13 mm | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Inspection Level 1, AQL 1.0 (Acceptance no. 5 for 200 pcs, Acceptance no. 10 for 500 pcs) | XS: Found 0 leaks (Sample 200), S: Found 1 leak (Sample 500), M: Found 3 leaks (Sample 500), L: Found 3 leaks (Sample 500), XL: Found 3 leaks (Sample 200) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Powder residue limit of 2.0 mg per glove | XS: 0.2 mg, S: 0.5 mg, M: 0.1 mg, L: 0.1 mg, XL: 0.2 mg | Pass |
| Extractable Protein Content | ASTM D5712-99 (Protein in Natural Rubber) | 200 µg/dm² Max | Less than 50 µg/dm² | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
- Dimension: Data is provided for each size (XS, S, M, L, XL).
- Watertight:
- XS & XL: Sample size 200 pcs each.
- S, M, L: Sample size 500 pcs each.
- Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
- Residual Powder: Sample size: 5 pcs.
- Extractable Protein Content: Sample size: 3 pcs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (glove), not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Study Type:
The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2022
WRP Asia Pacific SDN. BHD. % Michael Scaglione U.S. Agent SG Global, LLC 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685
Re: K211601
Trade/Device Name: Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: July 18, 2022 Received: July 19, 2022
Dear Michael Scaglione:
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.
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
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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 (QS) 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,
Bifeng Qian, M.D., Ph.D. 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) K211601
Device Name
Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free
Indications for Use (Describe)
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Submitter:
| Sponsor: | WRP Asia Pacific Sdn. Bhd. |
|---|---|
| Contact Name: | Muhammad Ameer Arief bin Mohd Mujab |
| Address: | WRP Asia Pacific Sdn. Bhd.Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 12th August 2022
2.0 Identification of the subject device:
| Trade Name | : Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LYY |
3.0 Predicate Device:
| PREDICATE DEVICE | |
|---|---|
| Manufacturer | Hi-Care Thai Gloves Co. Ltd. |
| Device Name | Palm Care Latex Examination Powder Free Glove |
| 510 (k) Number | K202377 |
| Regulatory Class | I |
| Product Code | LYY |
4.0 Description of The Device:
The Device meets all requirements of ASTM standard D3578 and FDA 21 CFR 880.6250.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile.
The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
5.0 Indication for use:
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Technological Characteristics Comparisons of the Device:
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| 510(k) Number | - | K202377 | K211601 | Different |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co. Ltd. | WRP Asia Pacific | Different |
| Material | ASTM D3578 | Natural rubber latex | Natural rubber latex | Similar |
| Color | - | Natural | Natural | Similar |
| Texture | - | Finger textured | Finger textured | Similar |
| Physical Properties | Meets | Meets | ||
| Before AgingTensile Strength:Ultimate Elongation:Stress at 500%Elongation: | ASTM D3578 | 18Mpa min650% min5.5Mpa max | 18MPa min650% min5.5Mpa max | Similar |
| After AgingTensile Strength:Ultimate Elongation:Stress at 500%Elongation: | ASTM D3578 | 14Mpa min500% min- | 14MPa min500% min- | Similar |
| Thickness:- Finger- Palm | ASTM D3578 | Meets0.08mm min0.08mm min | Meets0.11mm min0.09mm min | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Similar |
| CHARACTERISTICS | DEVICE PERFORMANCE | |||
| STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS | |
| Biocompatibility | Primary SkinIrritation - ISO10993-10:2010 (E)& Consumer ProductSafety Commission2012 Title 16,Chapter II, Part1500.3 & 1500.41 | PassesNot a primary skin irritantunder the conditions of thestudy. | Passes (Not a primary skinirritant)There was no erythema or oedemanoted on test site after (24±2),(48±2) and (72±2) hours. Theprimary Irritation Index (PII) was"0". | Similar |
| DermalSensitization- ISO10993-10: 2010 (E)& Consumer ProductSafety Commission2012 Title 16,Chapter II, Part1500.3 & 1500.41 | PassesNot a contact sensitizerunder the conditions of thestudy. | Passes (Not a contact sensitizer).There was no positive allergicreaction observed during thechallenge phase (at 0, 24 hoursand 48 hours) in animals treatedwith the test material andnegative control. | Similar | |
| Determination of InVitro CytotoxicityEffect over L929 CellLines by DirectContact Method, ISO10993-5: 2009 (E) | PassesNon-cytotoxic under theconditions of the study. | Qualitative reactivity grading ofcytotoxicity of the test itemtreatment was not greater than 2.Hence, the test item is consideredas 'Non-cytotoxic" to L929 mousefibroblast cells. | Similar | |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| Biocompatibility | Acute SystemicToxicity, ISO10993-11:2017 (E) | Not systemic toxic under theconditions of the study. | It is concluded that the productdid not induce any systemictoxicity. | Similar |
| Watertight (1000ml) | ASTM D5151 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Similar |
| Intended use / Indicationsfor use | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | Similar | |
| Size | Medical GloveGuidance Manual -Labeling | Extra smallSmallMediumLarge | Extra smallSmallMediumLargeExtra Large | Similar withadditional size, XLfor current device |
| Single use | Medical GloveGuidance Manual -Labeling | Single use | Single use | Similar |
| Sterility status | Medical GloveGuidance Manual -Labeling | Non-sterile | Non-sterile | Similar |
| Extractable ProteinContent | ASTM D5712-99 | 50 $µg/ dm²$ for all available sizes | <50 $µg/ dm²$ for all availablesizes | Similar |
| Shelf Life Claim | ASTM D7160 | No claim of shelf life | 3 years claim shelf life | Different |
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There are no significant differences between the subject and the predicate devices. The subject and predicate are identical in terms of intended use, materials, color, compliance with standards for physical properties, powder free and watertightness and sterility status. The sizes are similar with additional size, XL for current device.
They are slightly differed in thickness; whereby the current device is thicker than the predicate device. On another hand, qualitative reactivity grading of cytotoxicity of the current device treatment was not greater than 2. Hence, the test item is considered as `Non-cytotoxic" to L929 mouse fibroblast cells.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this Glove are summarized as per below.
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| TestMethod | Standard | PurposeofTesting | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanizedRubber andThermoplasticElastomers-Tension) | Toevaluatethe tensile(tension)propertiesof glove. | Tensilestrength | Min 18.0 MPa | Min 14.0 MPa | Extra small - 24.40 MPaSmall - 24.56 MPaMedium - 27.18 MPaLarge - 26.51 MPaExtra Large - 26.11 MPa | Extra small - 25.59 MPaSmall - 22.37 MPaMedium - 27.16 MPaLarge - 25.95 MPaExtra Large - 26.67 MPa | Pass |
| Ultimateelongation | Min 650% | Min 500% | Extra small - 792 %Small - 808 %Medium - 817 %Large - 811 %Extra Large - 783 % | Extra small - 802 %Small - 723 %Medium - 809 %Large - 829 %Extra Large -785 % | Pass | |||
| Stress at500%Elongation | Max. 5.5 MPa | - | Extra small - 4.77 MPaSmall - 5.11 MPaMedium - 4.55 MPaLarge - 4.85 MPaExtra Large - 5.22 MPa | Extra small - 4.39 MPaSmall - 4.85 MPaMedium - 4.61 MPaLarge - 3.17 MPaExtra Large - 5.09 MPa | Pass |
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| TestMethod | Standard | PurposeofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber -Measurementof Dimensions | Tomeasurethe length,width andthicknessof glove | LengthExtra small – Min 240 mmSmall – Min 240 mmMedium – Min 240 mmLarge – Min 240 mmExtra Large – Min 240 mmWidthExtra small – Max 80 mmSmall – Min 80 ± 10 mmMedium - Min 95 ± 10 mmLarge - Min 110 ± 10 mmExtra Large – Min 110mmThicknessFinger – Min 0.11 mmPalm – Min 0.09 mm | LengthExtra small – 243 mmSmall – 243 mmMedium - 243 mmLarge - 243 mmExtra Large – 243 mmWidthExtra small - 78 mmSmall – 84 mmMedium - 95 mmLarge – 106 mmExtra Large – 116 mmThicknessFinger Extra small – 0.14Small – 0.14 mmMedium – 0.15 mmLarge – 0.15 mmExtra Large – 0.16 mmPalm Extra small - 0.12Small – 0.12 mmMedium – 0.12 mmLarge – 0.12 mmExtra Large - 0.13 mm | PassPassPass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
| Watertight | ASTMD5151(StandardTest Methodfor Detectionof Holes inMedicalGloves) | To detectholes thatleak waterand therebycompromisetheusefulness ofthe glove. | Size: XSSample size: 200 pcsInspection level: G1AQL: 1.0,Acceptance No. 5, Found 0 | The batch size for this sampling is 35,001 to 150,000.Hence, according to the single sampling plan GI, thesample to be drawn under code L is equivalent to 200pieces with accept 5 and reject 6 to be accepted underAQL 1.0. During the test, 0 pieces were found with leaks.Hence it falls within the acceptance criteria. | Pass |
| Watertight | Size: SSample size: 500 pcsInspection level: G1AQL: 1.0,Acceptance No. 10, Found 1 | The batch size for this sampling is 500,001 to over.Hence, according to the single sampling plan GI, thesample to be drawn under code N equivalent to 500pieces with accept 10 and reject 11 to be accepted underAQL 1.0. During the test, 1 piece was found with leaks.Hence it falls within the acceptance criteria. | Pass | ||
| Watertight | Size: MSample size: 500 pcsInspection level: G1AQL: 1.0,Acceptance No. 10, Found 3 | The batch size for this sampling is 500,001 to over.Hence, according to the single sampling plan GI, thesample to be drawn is under code N equivalent to 500pieces with accept 10 and reject 11 to be accepted underAQL 1.0. During the test, 3 pieces were found with leaks.Hence it falls within the acceptance criteria. | Pass | ||
| Watertight | Size: LSample size: 500 pcsInspection level: G1AQL: 1.0,Acceptance No. 10, Found 3 | The batch size for this sampling is 500,001 to over.Hence, according to the single sampling plan GI, thesample to be drawn is under code M equivalent to 500pieces with accept 10 and reject 11 to be accepted underAQL 1.0. During the test, 3 pieces were found with leaks.Hence it falls within the acceptance criteria. | Pass | ||
| Watertight | Size: XLSample size: 200 pcsInspection level: G1AQL: 1.0,Acceptance No. 5, Found 3 | The batch size for this sampling is 35,001 to 150,000.Hence, according to the single sampling plan GI, thesample to be drawn is under code L equivalent to 200pieces with accept 5 and reject 6 to be accepted underAQL 1.0. During the test, 3 pieces were found withleaks. Hence it falls within the acceptance criteria. | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results(Sample size: 5 pcs) | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Have a powder residue limitof 2.0 mg per glove | Extra small – 0.2 mgSmall – 0.5 mgMedium – 0.1 mgLarge – 0.1 mgExtra Large – 0.2 mg | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results(Sample size: 3 pcs) | Status |
|---|---|---|---|---|---|
| ExtractableProteinContent | ASTM D5712-99(Standard TestMethod for Analysisof Protein in NaturalRubber) | To determine theextractable proteinin gloves | 200 µg/ dm² Max | Less than 50 µg/ dm² | Pass |
The shelf-life study claim of this Glove describes the effect of accelerated aging on visual appearance, hole defect and physical properties for establishing a 3 years shelf life based on ASTM D7160.
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K202377.
§ 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.