(86 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.
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile 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 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 document describes the acceptance criteria and performance data for the "White Nitrile Powder-Free Patient Examination Glove, Non Sterile" (K222713). This medical device is a patient examination glove and the testing performed aligns with engineering and material specifications, rather than AI/software performance. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance (K222713) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Tensile Strength: Before aging: Min 14.0 MPa; After aging: Min 14.0 MPa Ultimate Elongation: Before aging: Min 500%; After aging: Min 400% | Tensile Strength: Before aging: XS – 28.8 MPa, S – 28.6 MPa, M – 28.9 MPa, L – 28.1 MPa, XL – 28.7 MPa After aging: XS – 30.8 MPa, S – 31.1 MPa, M – 31.8 MPa, L – 31.9 MPa, XL – 30.8 MPa Ultimate Elongation: Before aging: XS – 540%, S – 540%, M – 530%, L – 540%, XL – 540% After aging: XS – 460%, S – 480%, M – 480%, L – 480%, XL – 480% | Pass |
| Dimension | ASTM D3767 (Rubber—Measurement of Dimensions) | Length: Min 240 mm Width: XS: 70 ± 10 mm S: 80 ± 10 mm M: 95 ± 10 mm L: 110 ± 10 mm XL: 120 ± 10 mm Thickness (Finger & Palm): Min 0.05 mm | Length: XS: 248 mm, S: 245 mm, M: 244 mm, L: 248 mm, XL: 244 mm Width: XS: 75 mm, S: 85 mm, M: 95 mm, L: 106 mm, XL: 116 mm Thickness: Finger: 0.09 mm (all sizes) Palm: 0.06 mm (all sizes) | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 315 pcs (Inspection level G1, AQL 1.5, Acceptance No. 10) | Results for 315 pieces (Batch size 150,001 to 500,000): XS: 1 piece with leaks S: 2 pieces with leaks M: 2 pieces with leaks L: 4 pieces with leaks XL: 3 pieces with leaks (All within the acceptance criteria of 10 leaks or less for the sample size.) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove (< 2 mg/glove) | Results (5 pcs sample size): XS: 0.24 mg/glove S: 0.28 mg/glove M: 0.34 mg/glove L: 0.32 mg/glove XL: 0.38 mg/glove | Pass |
| Biocompatibility | ISO 10993 Part 10 (Irritation and Sensitization), 16 CFR Part 1500 (Consumer Product Safety Commission) | Primary Skin Irritation: Non-irritant or non-sensitizer Dermal Sensitization: Non-irritant or non-sensitizer | Primary Skin Irritation: Test material did not cause an irritant response; deemed 'Negligible' Dermal Sensitization: Test material did not produce a skin sensitization effect in guinea pigs | Pass |
| Biocompatibility | ISO 10993 Part 11 (Systemic Toxicity) | No acute systemic toxicity | Test item did not induce any acute systemic toxicity in Swiss albino mice. | Pass |
2. Sample size used for the test set and the data provenance:
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Dimension (Length, Width, Thickness): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Watertight: A sample size of 315 pieces per batch was used, adhering to a single sampling plan G1 for a batch size of 150,001 to 500,000.
- Residual Powder: A sample size of 5 pieces per size was used.
- Biocompatibility: The standard test methods (ISO 10993-10 for irritation/sensitization, ISO 10993-11 for systemic toxicity) imply specific animal models (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity), but the exact number of animals is not detailed in this summary.
Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state whether the studies were retrospective or prospective, although laboratory testing like this is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The ground truth for device performance in this context is established by adherence to recognized international technical standards (ASTM, ISO) and specific criteria outlined for physical, chemical, and biological properties, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
This is not applicable as 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:
This is not applicable as the device is a patient examination glove, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a patient examination glove, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for this device is based on objective measurements and laboratory testing results compared against established international consensus standards (ASTM, ISO) for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.
8. The sample size for the training set:
This is not applicable as the device is a patient examination glove and does not involve an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
This is not applicable.
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December 3, 2022
Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126
Re: K222713
Trade/Device Name: White 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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 -S
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) K222713
Device Name WHITE 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) |
| 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.
K222713 510K Summary
Trade Name : White 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 | : | 8/1/2022 |
2.0 ldentification of the subject device:
| Trade Name: | White 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:
K171615
Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Company: Shandong Xingyu Gloves Co., Ltd
4.0 Description of The Subject Device:
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile 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 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 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 White 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 | ||
|---|---|---|---|---|---|
| PREDICATEWHITE | CURRENTWHITE | ||||
| 510(k) Number | - | K171615 | K222713 | ||
| Manufacturer(s) | - | Shandong Xingyu Gloves Co., Ltd | Safeskin Retailing (HK) Limited | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | White | White | Same | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Handedness | - | Ambidextrous | Ambidextrous | Same | |
| Physical Properties | Before AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 18-25Mpa560-600% | 28.1 – 32.9 Mpa530 - 600% | Different butwithin the ASTMstandard |
| After Aging TensileStrength:Ultimate Elongation: | 17-21Mpa460-560% | 30.8 – 35.9 Mpa460 - 560% | Different butwithin the ASTMstandard | ||
| Thickness: | - Finger- Palm | ASTM D6319 | 0.08mm0.08mm | Min 0.09mm 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 | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | ||
| PREDICATE | CURRENT | ||||
| WHITE | WHITE | ||||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16,Chapter II, Part 1500 | Under the conditions of thisstudy, the test article was a non-irritant or non-sensitizer.SKIN IRRITATION DERMAL andSENSITIZATION STUDIES MeetsISO 10993-10: Third Edition2010-08-01 | Under conditions of this study, thetest material did not cause anirritant response. The PrimaryIrritant Response Category isdeemed 'Negligible' | Same | |
| 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 article was a non-irritant or non-sensitizer.SKIN IRRITATION DERMAL andSENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01 | Under conditions of this study,thetest material did not produce a skinsensitization effect in the guineapigs. | Same | ||
| Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Tested | Under conditions of this study,thetest item did not induce anyacute systemic toxicity in Swissalbino mice. | Different. Thesubject glove wastested usingsystemic toxicity testand passed, but thePredicate did nothave the testperformed | ||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | ||
| PREDICATEWHITE | CURRENTWHITE | ||||
| Watertight (1000ml) | ASTM D5151:2019 | Meets 21 CFR 800.20 ASTM D6319-10(Reapproved 2015) Tested in accordance with ASTMD5151 (Reapproved 2015) withacceptable results | 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 | - | Powder Free Nitrile PatientExamination Gloves, White Color isa disposable device intended formedical purposes that is worn onthe examiner'shand or finger toprevent contamination betweenpatientand 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. | Same | |
| Size | Medical GloveGuidance Manual -Labeling | SmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra Large | SimilarThe subject glovehas an additionalsize Extra Small,which the Predicatedoes not offer | |
| Single use | Medical GloveGuidance Manual –Labeling | Single Patient 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 | |||
|---|---|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412(Standard Test Methodfor Vulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Beforeaging | Afteraging | Beforeaging | After aging | |
| Min 14.0MPa | Min 14.0MPa | XS – 28.8 | XS – 30.8 | Pass | ||||
| S – 28.6 | S – 31.1 | |||||||
| M – 28.9 | M – 31.8 | |||||||
| L – 28.1 | L – 31.9 | |||||||
| XL – 28.7 | XL – 30.8 | |||||||
| Ultimateelongation | Min500% | Min400% | XS – 540 | XS – 460 | Pass | |||
| S – 540 | S – 480 | |||||||
| M – 530 | M – 480 | |||||||
| L – 540 | L – 480 | |||||||
| XL – 540 | XL – 480 |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber—MeasurementofDimensions | To measure thelength, width andthickness of glove | X-Small | LengthMin 240 mmWidth$70 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length248 mmWidth75 mmThickness0.09 mm0.06 mm | PassPassPass | |
| Small | LengthMin 240 mmWidth$80 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length245 mmWidth85 mmThickness0.09 mm0.06 mm | PassPassPass | ||||
| Medium | LengthMin 240 mmWidth$95 \pm 10$ mmThicknessFinger – min 0.05mmPalm - min 0.05mm | Length244 mmWidth95 mmThickness0.09 mm0.06 mm | PassPassPass | ||||
| Large | LengthMin 240 mmWidth$110 \pm 10$ mm | Length248 mmWidth106 mm | PassPass | ||||
| Thickness | Finger – min 0.05mm | Thickness | 0.09 mm | Pass | |||
| Palm – min 0.05mm | 0.06 mm | ||||||
| Length | Min 240 mm | Length | 244 mm | Pass | |||
| X-Large | Width | $120 \pm 10$ mm | Width | 116 mm | Pass | ||
| Thickness | Finger – min 0.05mm | Thickness | 0.09 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, 1piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size S During thetest, 2piece 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, 4piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size XL During thetest, 3piece was foundwith leaks. Hence it fallswithin the acceptancecriteria. | Pass |
| 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 size : 5 pcsResult XS :0.24mg/gloveResult S :0.28mg/gloveResult M :0.34mg/gloveResult L :0.32mg/gloveResult XL :0.38mg/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 "White 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 device "Xinqyu Nitrile Powder Free Patient Examination Gloves, White Color" (K171615)
§ 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.