(40 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.
Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of glove. | ||
| - Tensile Strength (Before Aging) | Min 14.0 MPa | XS – 28.8 MPa; S – 29.2 MPa; M – 28.0 MPa; L – 27.2 MPa; XL – 26.8 MPa | |
| - Tensile Strength (After Aging) | Min 14.0 MPa | XS – 30.8 MPa; S – 32.2 MPa; M – 31.0 MPa; L – 31.6 MPa; XL – 30.6 MPa | |
| - Ultimate Elongation (Before Aging) | Min 500% | XS – 520%; S – 550%; M – 540%; L – 560%; XL – 540% | |
| - Ultimate Elongation (After Aging) | Min 400% | XS – 460%; S – 470%; M – 480%; L – 460%; XL – 450% | |
| Dimension (ASTM D3767) | To measure the length, width and thickness of glove | ||
| - Length | Min 240 mm (for sizes S, M, L, XL), 243 mm (for XS) | XS: 243 mm; S: 243 mm; M: 243 mm; L: 242 mm; XL: 248 mm | |
| - Width | 70 ± 10 mm (XS); 80 ± 10 mm (S); 95 ± 10 mm (M); 110 ± 10 mm (L); 120 ± 10 mm (XL) | XS: 75.0 mm; S: 85.0 mm; M: 95.0 mm; L: 106 mm; XL: 115 mm | |
| - Finger Thickness | Min 0.05 mm | XS: 0.10 mm; S: 0.10 mm; M: 0.10 mm; L: 0.10 mm; XL: 0.10 mm | |
| - Palm Thickness | Min 0.05 mm | XS: 0.06 mm; S: 0.06 mm; M: 0.06 mm; L: 0.06 mm; XL: 0.06 mm | |
| Watertight (ASTM D5151) | To detect holes that leak water | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | For Size XS: 3 pieces with leaks; For Size S: 1 piece with leaks; For Size M: 2 pieces with leaks; For Size L: 2 pieces with leaks; For Size XL: 1 piece with leaks. All these results fall within the acceptance criteria. |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder | Less than 2 mg per glove (< 2mg/glove) | XS: 0.33 mg/glove; S: 0.28 mg/glove; M: 0.26 mg/glove; L: 0.30 mg/glove; XL: 0.34 mg/glove (Note: Document has two entries for XL, selecting the lowest one for consistency) |
| Biocompatibility | |||
| - Primary Skin Irritation (ISO 10993-10) | Evaluate irritant response | "Under the conditions of this study, the device is non-irritant and non-sensitizer" (Predicate criteria) | "Under conditions of this study, the test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'." (Current device) |
| - Dermal Sensitization (ISO 10993-10) | Evaluate skin sensitization effects | "Under the conditions of this study, the test device is non-irritant and non-sensitizer." (Predicate criteria) | "Under conditions of this study, the test material did not produce a skin sensitization effect in the guinea pigs." (Current device) |
| - Acute Systemic Toxicity (ISO 10993-11) | Assess systemic toxicity | Not Tested (Predicate) | "Under conditions of this study, the test item did not induce any systemic toxicity in Swiss albino mice." (Current device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes are specified by size (XS, S, M, L, XL) with individual results reported. However, the exact number of gloves tested for each size isn't explicitly stated in the summary, only the aggregate outcome for each size category.
- Dimension: Results are reported for each glove size (X-Small, Small, Medium, Large, X-Large), but the specific sample size for each dimension measurement per size is not explicitly stated in the summary.
- Watertight: The sample size was 315 pieces per size, for an AQL (Acceptable Quality Limit) test, based on a batch size of 150,001 to 500,000.
- Residual Powder: The sample size was 5 pieces per glove size.
- Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): The sample sizes for these biological tests are not specified in the provided tables, but "guinea pigs" and "Swiss albino mice" are mentioned as test subjects for sensitization and systemic toxicity, respectively.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in this summary. The submitter is "Safeskin Retailing (HK) Limited" (Hong Kong), but where the actual testing took place or the data was collected isn't detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is a physical glove, not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests are objective measurements according to established ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for a physical device and not an AI/ML diagnosis/detection system where adjudication of expert opinions would be necessary. The tests are objective measurements against defined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for an AI/ML powered medical device. The submitted device is a physical examination glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/ML powered medical device. The submitted device is a physical examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is established by adherence to recognized international standards and specifications for medical gloves, such as:
- ASTM D412: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers—Tension.
- ASTM D3767: Standard Practice for Rubber—Measurement of Dimensions.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10: Biological evaluation of medical devices – Tests for irritation and skin sensitization.
- ISO 10993-11: Biological evaluation of medical devices – Tests for systemic toxicity.
- ISO 2859: Sampling Procedures and Tables for Inspection by Attributes.
These standards define objective measurement methodologies and acceptable ranges for various physical and biocompatibility properties.
8. The sample size for the training set
Not applicable. This is a physical device, and AI/ML "training sets" are not part of its development or testing for this submission.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML development.
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October 18, 2022
Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126
Re: K222721
Trade/Device Name: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 5, 2022 Received: September 8, 2022
Dear Stephan Toupan:
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 (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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222721
Device Name VIOLET NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE
Indications for Use (Describe)
A nitrile patient examination glove is a disposable device made of nitrile rubber 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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Image /page/3/Picture/0 description: The image contains the logo for Safeskin Retailing. The logo consists of a blue geometric shape on the left and the words "safeskin retailing" on the right. The geometric shape is a stylized letter "K" formed by two triangles, one in a darker shade of blue and the other in a lighter shade. The text "safeskin retailing" is in a bold, sans-serif font, with "safeskin" on the top line and "retailing" on the bottom line.
K222721 510K Summary
Trade Name : Violet Nitrile Powder-free Patient
Examination Glove, Non-Sterile
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| 1.0 | Submitter:Name | : Alvin Ho |
|---|---|---|
| Address | : Safeskin Retailing (HK) Limited26th Floor, Beautiful Group Tower, 77 Connaught RoadCentral, Hong Kong | |
| Phone No. | : +6012 826 5625 | |
| Date of Summary Prepared | : 12 October 2022 |
2.0 ldentification of the subject device:
| Trade Name: | Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile |
|---|---|
| Common Name: | Patient Examination Gloves |
| Classification Name : | Patient Examination Gloves |
| Device Classification | 1 |
| Regulation Number : | 21 CFR 880.6250 |
| Product Code | LZA |
3.0 Predicate Device:
K143289
Non-Sterile, Powder Free Nitrile Examination Gloves - Violet Color Company: YTY Industry (Manjung) Sdn Bhd
4.0 Description of The Subject Device:
Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
5.0 Indication for use:
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
6.0
Comparison of the Technological Characteristics of the Device:
The Violet Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATEK143289VIOLET | CURRENTK222721VIOLET | |||
| 510(k) Number | - | K143289 | K222721 | |
| Manufacturer(s) | - | YTY Industry (Manjung) Sdn Bhd. | Safeskin Retailing (HK) Limited | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Violet | Violet | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Handedness | - | Ambidextrous | Ambidextrous | Same |
| Physical Properties | ASTM D6319 | |||
| Before AgingTensile Strength:Ultimate Elongation: | - | 23.33 - 29.11Mpa520 - 580% | 26.8 – 32.3 Mpa520 - 600% | Different butwithin the ASTMstandard |
| After Aging TensileStrength:Ultimate Elongation: | - | 27.39 - 30.82Mpa440 - 500% | 30.6 – 35.3 Mpa450 - 540 % | Different butwithin the ASTMstandard |
| Thickness:- Finger- Palm | ASTM D6319 | |||
| 0.09 - 0.11mm0.06 - 0.07mm0.05-0.06mm | Min 0.10mm for (XS, S, M, L XL)Min 0.06mm for (XS, S, M, L XL) | Different butwithin the ASTMstandard | ||
| Powder Free | ASTM D6124 | Below 2mg of residual powder | Below 2mg of residual powder | Different butwithin the ASTMstandard |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATEK143289VIOLET | CURRENTK222721VIOLET | |||
| Biocompatibility | Primary Skin Irritation– ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the conditions of thisstudy, the device is non-irritantand non-sensitizer | Under conditions of this study, thetest material did not cause anirritant response. The PrimaryIrritant Response Category isdeemed 'Negligible' | Same |
| Biocompatibility | Dermal Sensitization-ISO 10993-10: 2010(E) & Consumer ProductSafety Commission,Title 16,Chapter II, Part1500.3 (c) (4) | Under the conditions of thisstudy, the test device is non-irritant and non-sensitizer. | Under conditions of this study,thetest material did not produce a skinsensitization effect in the guineapigs. | Same |
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Tested | Under conditions of this study,thetest item did not induce anysystemic toxicity in Swiss albinomice. | Different. Thesubject glove wastested usingsystemic toxicity testand passed, but thePredicate did nothave the testperformed |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATEK143289VIOLET | CURRENTK222721VIOLET | |||
| Watertight (1000ml) | ASTM D5151:2019 | AQL 2.4Result : 0 | Meets• 21 CFR 800.20• ASTM D6319-10(Reapproved 2015)Tested in accordance with ASTMD5151 (Reapproved 2015) withacceptable resultsAt an AQL 1.5 | Same |
| Intended use / Indicationsfor use | - | A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiners hand or finger toprevent contamination betweenpatient and examiner | A Nitrile patient examination gloveis a disposable device made ofnitrile rubber intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. | Similar |
| Size | Medical GloveGuidance Manual –Labeling | Medium | Extra SmallSmallMediumLargeExtra Large | SimilarThe subject glovehas a size ExtraSmall, the Predicatedoes not |
| Single use | Medical GloveGuidance Manual –Labeling | Single Use | Single Use | Same |
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There are no significant differences between the two devices. They are the same or similar in terms of intended use, primary material (Nitrile), design, physical properties, thickness, powder-free compliance, color, and biocompatibility assessments.
Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| PhysicalProperties | ASTM D412(Standard Test Methodfor Vulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | XS – 28.8S – 29.2M – 28.0L – 27.2XL – 26.8 | XS – 30.8S – 32.2M – 31.0L – 31.6XL – 30.6 | Pass |
| Ultimateelongation | Min500% | Min400% | XS – 520S – 550M – 540L – 560XL – 540 | XS – 460S – 470M – 480L – 460XL – 450 | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber—MeasurementofDimensions | To measure thelength, width andthickness ofglove | X-Small | Length | 243 mm | Pass | |
| Width$70 \pm 10$ mm | 75.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mm | 0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | Pass | |||||
| Small | LengthMin 240 mm | 243 mm | Pass | ||||
| Width$80 \pm 10$ mm | 85.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mm | 0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | Pass | |||||
| Medium | LengthMin 240 mm | 243 mm | Pass | ||||
| Width$95 \pm 10$ mm | 95.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mm | 0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | Pass | |||||
| Large | LengthMin 240 mm | 242 mm | Pass | ||||
| Width$110 \pm 10$ mm | 106 mm | Pass | |||||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.06 mm | ||||||
| Length | Min 240 mm | Length | 248 mm | Pass | |||
| X-Large | Width | $120 \pm 10$ mm | Width | 115 mm | Pass | ||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.06 mm |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of HolesinMedical Gloves) | To detect holesthat leak water andtherebycompromise theusefulness of theglove. | Sample size: 315 pcsInspection level: G1AQL: 1.5, Acceptance No. 10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code M equivalentto 315 pieces with accept10 and reject 11 to beaccepted under AQL1.5.For Size XS During thetest, 3piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size S During thetest, 1piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size M During thetest, 2piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size L During thetest, 2piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size XL During thetest, 1piece was foundwith leaks. Hence it fallswithin the acceptancecriteria. | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard Test Methodfor Residual Powder onMedical Gloves) | To determine theamount of residualand non-powdersolids found ongloves | Less than 2 mg per gloveRequirement : <2mg/glove | Sample sizeResultResult XSResult SResult MResult LResult XL | : 5 pcs:0.33mg/glove:0.28mg/glove:0.26mg/glove:0.30mg/glove:0.40mg/glove:0.34mg/glove | Pass |
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8.0 Non-clinical performance testing methods full titles:
- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— O Tension
- ASTM D573 Test Method for Rubber-Deterioration in an Air Oven x ASTM D3578 o Specification for Rubber Examination Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical o Application
- ASTM D5151 Test Method for Detection of Holes in Medical Gloves o
- ASTM D6124 Test Method for Residual Powder on Medical Gloves O
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show O that under the conditions of the testing, there is no difference inphysical attributes between the proposed device and the predicate device.
Biocompatibility Testing utilizing: ISO 10993 Biological Evaluation ofMedical 9.0 Devices:
- ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation andDermal O Magnuson/Kligman Sensitization performed.
- ISO 10993 Part 11: Tests for assessment of Systemic Toxicity O
10.0 Summary of Clinical Testing:
No clinical studies are included in this submission.
11.0 Differences:
There are no significant differences between the current glove and the predicate. They are identical in terms of their intended use, base materials, design, color, and manufacturing process.
Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject device: Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile, is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices K143289.
§ 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.