(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
Black 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 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 document describes the non-clinical performance testing for a medical device: "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile." This submission is a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Before Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 28.9 MPa, S: 27.8 MPa, M: 28.7 MPa, L: 28.3 MPa, XL: 28.0 MPa | Pass |
| Before Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 500% | XS: 540%, S: 530%, M: 560%, L: 540%, XL: 540% | Pass |
| After Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 31.7 MPa, S: 32.1 MPa, M: 32.4 MPa, L: 31.9 MPa, XL: 31.5 MPa | Pass |
| After Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 400% | XS: 480%, S: 470%, M: 490%, L: 480%, XL: 490% | Pass |
| Dimensions (ASTM D3767) | ||||
| Length (all sizes) | Min 240 mm | XS: 244 mm, S: 245 mm, M: 244 mm, L: 243 mm, XL: 242 mm | Pass | |
| Width | ||||
| XS | $70 \pm 10$ mm | 74.0 mm | Pass | |
| S | $80 \pm 10$ mm | 85.0 mm | Pass | |
| M | $95 \pm 10$ mm | 95.0 mm | Pass | |
| L | $110 \pm 10$ mm | 106 mm | Pass | |
| XL | $120 \pm 10$ mm | 117 mm | Pass | |
| Thickness - Finger (all sizes) | Min 0.05 mm | 0.10 mm (for XS, S, M, L, XL) | Pass | |
| Thickness - Palm (all sizes) | Min 0.05 mm | 0.06 mm (for XS, S, M, L, XL) | Pass | |
| Watertight | ASTM D5151, ISO 2859 | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | The test found 1 leak for XS, 3 for S, 2 for M, 3 for L, and 1 for XL. All are within the acceptance criteria (total max 10 leaks for the batch size). | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | XS: 0.26 mg/glove, S: 0.32 mg/glove, M: 0.28 mg/glove, L: 0.34 mg/glove, XL: 0.38 mg/glove | Pass |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not cause an irritant response. Primary Irritant Response Category deemed 'Negligible'. | Pass |
| Dermal Sensitization | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not produce a skin sensitization effect in the guinea pigs. | Pass |
| Cytotoxicity - MEM Elution | ISO 10993-5:2009 | Passes | The Systemic Toxicity study was conducted as the accepted alternative to the cytotoxic test. | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Not explicitly stated as "Passes" in a single column but the predicate did not test this; results show device passed. | The test item did not induce any systemic toxicity in Swiss albino mice. | Pass |
2. Sample Sizes and Data Provenance:
- Test Set (Current Device):
- Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but tests were performed for different glove sizes (XS, S, M, L, XL). ASTM D412 and D6319 typically specify sample sizes.
- Dimensions (Length, Width, Thickness): Not explicitly stated, but performed for all glove sizes (XS, S, M, L, XL). ASTM D3767 specifies measurement practices.
- Watertight: 315 pieces (for a batch size of 150,001 to 500,000).
- Residual Powder: 5 pieces.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Not explicitly stated for each test, but typically involves animal subjects (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity).
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would be prospective for this specific device.
3. Number of Experts and Qualifications for Ground Truth for the Test Set:
This document describes non-clinical performance testing of a physical medical device (gloves). The ground truth for this type of device is established through standardized laboratory tests according to recognized ASTM and ISO standards, not via expert consensus or clinical evaluation in the same way as, for example, an AI diagnostic tool. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context doesn't directly apply as it would for a clinical study or AI performance evaluation. The "experts" are implicitly the technicians and scientists performing the tests according to the defined standards.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements and evaluations against specified pass/fail criteria from recognized standards (ASTM, ISO). There is no "adjudication" between multiple human readers or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging tools where human readers are involved in interpreting results. This submission is for a physical medical device (gloves) and focuses on non-clinical performance characteristics.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used:
The ground truth used is based on:
- Standardized Test Methods: Adherence to established and recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards.
- Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation, dimensions, powder content).
- Qualitative Assessments: Outcomes of biocompatibility tests (irritation, sensitization, toxicity) as defined by ISO standards on animal models.
- Statistical Sampling: For watertightness, an Acceptance Quality Limit (AQL) statistical sampling plan (ISO 2859) is used.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of medical device which undergoes standardized physical and chemical testing. This is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set. The device's performance is evaluated directly against pre-established, widely accepted industry standards and regulatory requirements for medical examination gloves.
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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: K222715
Trade/Device Name: Black 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 -S
Bifeng Oian, 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) K222715
Device Name
BLACK 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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510(k) Summary K222715 As required by 21CFR§807.92(c)
| 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 | : 11 November 2022 |
2.0 Identification of the subject device:
| Trade Name: | Black 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:
K190942
Trade Name : Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co., Ltd
Description of The Subject Device: 4.0
Black 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 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 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 Black 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
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATEBLACK | CURRENTBLACK | COMPARISONANALYSIS |
| 510(k) Number | - | K190942 | K222715 | |
| Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | Safeskin Retailing (HK) Limited | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Handedness | - | Ambidextrous | Ambidextrous | Same |
| Physical PropertiesBefore AgingTensile Strength:Ultimate Elongation:After Aging TensileStrength:Ultimate Elongation: | ASTM D6319 | 14Mpa, min500% min14Mpa, min400% min | 27.8 – 33.1 Mpa530 -600%31.5 – 35.3 Mpa470- 550% | Different butwithin the ASTMstandardDifferent butwithin the ASTMstandard |
| Thickness:- Finger- PalmPowder Free | ASTM D6319ASTM D6124 | 0.05mm min0.05mm min< 2mg per glove | Min 0.10mm for (XS, S, M, L, XL)Min 0.06mm for (XS, S, M, L, XL)Below 2mg of residual powder | Different butwithin the ASTMstandardSimilar |
| STANDARDS | DEVICE PERFORMANCE | |||
| CHARACTERISTICS | PREDICATEBLACK | CURRENTBLACK | COMPARISONANALYSIS | |
| Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Passes | 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) | Passes | Under conditions of this study,thetest material did not produce a skinsensitization effect in the guineapigs. | Same |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 | Passes | The Systemic Toxicity study wasconducted as the acceptedalternative to the cytotoxic test | Different - butadditional test of AcuteSystemic Toxicity isconducted and passed | |
| 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 | |
| PREDICATEBLACK | CURRENTBLACK | |||
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTM D6319-10and ASTM D5141-06 (Reapproved2011), G-1, AQL 2.5 | Meets• 21 CFR 800.20• ASTM D6319-10(Reapproved 2015)Tested in accordance with ASTMD5151 (Reapproved 2015) withacceptable resultsAt an AQL 1.5 | Different, but withinASTM standard; AQL1.5 is more stringentthan AQL 2.5 |
| Intended use | - | The Nitrile Powder Free Patientexamination glove is a non-steriledisposable device intended formedical purpose that is worn onthe examiners hands 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 | Extra SmallSmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual -Labeling | Single Use | Single Use | Same |
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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.
| 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 – 28.9S – 27.8M – 28.7L – 28.3XL – 28.0 | XS – 31.7S – 32.1M – 32.4L – 31.9XL – 31.5 | Pass |
| Ultimateelongation | Min500% | Min400% | XS – 540S – 530M – 560L – 540XL – 540 | XS – 480S – 470M – 490L – 480XL – 490 | 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 | LengthMin 240 mm | Length244 mm | Pass |
| Width$70 \pm 10$ mm | Width74.0 mm | Pass | ||||
| ThicknessFinger – min 0.05mmPalm – min 0.05mm | Thickness0.10 mm0.06 mm | Pass | ||||
| Small | LengthMin 240 mm | Length245 mm | Pass | |||
| Width$80 \pm 10$ mm | Width85.0 mm | Pass | ||||
| ThicknessFinger – min 0.05mmPalm – min 0.05mm | Thickness0.10 mm0.06 mm | Pass | ||||
| Medium | LengthMin 240 mm | Length244 mm | Pass | |||
| Width$95 \pm 10$ mm | Width95.0 mm | Pass | ||||
| ThicknessFinger – min 0.05mmPalm – min 0.05mm | Thickness0.10 mm0.06 mm | Pass | ||||
| Large | LengthMin 240 mm | Length243 mm | Pass | |||
| Width$110 \pm 10$ mm | Width106 mm | Pass | ||||
| Thickness | Finger – min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.06 mm | Pass | ||
| Length | Min 240 mm | Length | 242 mm | Pass | ||
| X-Large | Width | $120 \pm 10$ mm | Width | 117 mm | Pass | |
| Thickness | Finger - min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.06 mm | Pass |
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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, 3piece 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, 3piece 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 sizeResult XSResult SResult MResult LResult XL | : 5 pcs:0.26mg/glove:0.32mg/glove:0.28mg/glove:0.34mg/glove: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.
- ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal O Magnuson/Kligman Sensitization performed.
- o ISO 10993 - Part 11: Tests for assessment of Systemic Toxicity
9.0 Summary of Clinical Testing
No clinical testing is included in this submission
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject "Black 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 predicate K190942.
§ 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.