(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
Blue 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.
Based on the provided document, the device in question is a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. This is not a medical imaging AI device or a diagnostic AI device. The document is a 510(k) Premarket Notification summary for a medical glove, which is a physical device, and the testing conducted is for physical and chemical properties, not algorithmic performance.
Therefore, the requested information, which pertains to the acceptance criteria and study designs for AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance, training set details), is not applicable to this document.
The document describes non-clinical testing for the glove, focusing on properties like tensile strength, elongation, dimensions, watertight integrity, residual powder, and biocompatibility.
However, I can extract and present the acceptance criteria and performance data as per the document's content, formatted as a table, making it clear that this applies to a physical device and not an AI/ML system.
Acceptance Criteria and Device Performance for Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K222720)
The following table summarizes the non-clinical acceptance criteria and the reported performance of the device. It's crucial to understand that this concerns the physical and chemical properties of a medical glove, not the performance of an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Tensile Strength | ASTM D412 | Before Aging: Min 14.0 MPa | Before Aging: XS - 28.1 MPa, S - 28.4 MPa, M - 29.2 MPa, L - 28.0 MPa, XL - 28.9 MPa | Pass |
| After Aging: Min 14.0 MPa | After Aging: XS - 31.2 MPa, S - 30.9 MPa, M - 32.3 MPa, L - 31.0 MPa, XL - 31.3 MPa | Pass | ||
| Ultimate Elongation | ASTM D412 | Before Aging: Min 500% | Before Aging: XS - 540%, S - 530%, M - 550%, L - 540%, XL - 540% | Pass |
| After Aging: Min 400% | After Aging: XS - 460%, S - 460%, M - 470%, L - 490%, XL - 480% | Pass | ||
| Dimensions | ASTM D3767 | |||
| Length (all sizes) | Min 240 mm | XS - 244 mm, S - 242 mm, M - 242 mm, L - 243 mm, XL - 244 mm | Pass | |
| Width | XS: $70 \pm 10$ mm; S: $80 \pm 10$ mm; M: $95 \pm 10$ mm; L: $110 \pm 10$ mm; XL: $120 \pm 10$ mm | XS - 74.0 mm, S - 85.0 mm, M - 95.0 mm, L - 106 mm, XL - 115 mm | Pass | |
| Thickness (Finger) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.10 mm | Pass | |
| Thickness (Palm) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.06 mm | Pass | |
| Watertight Integrity | ASTM D5151 | AQL 1.5, Acceptance No. 10 (for sample size 315 pcs) | For sample size 315 pcs (batch size 150,001 to 500,000): XS - 4 leaks, S - 2 leaks, M - 3 leaks, L - 1 leak, XL - 2 leaks. All within acceptance criteria. | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove (<2mg/glove) | XS - 0.30 mg/glove, S - 0.26 mg/glove, M - 0.34 mg/glove, L - 0.38 mg/glove, XL - 0.40 mg/glove. All are below 2 mg/glove. | Pass |
| Biocompatibility | ISO 10993-10, 16 CFR Part 1500 | Not an irritant | The test material did not cause an irritant response. Primary Irritant Response Category deemed 'Negligible'. | Same |
| Primary Skin Irritation | ISO 10993-10, 16 CFR Part 1500 | Not a sensitizer | The test material did not produce a skin sensitization effect in guinea pigs. | Same |
| Dermal Sensitization | ISO 10993-11 | Device extracts do not pose a systemic toxicity concern | The test item did not induce any systemic toxicity in Swiss albino mice. | Same |
| Acute Systemic Toxicity |
Regarding the AI/ML specific questions (2-9):
The device is a non-AI medical product (patient examination glove). Therefore, the concepts and requirements typically associated with AI/ML device evaluations (such as sample size for AI test and training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this 510(k) submission. No AI or machine learning components are mentioned or implied in the document for this device. The testing conducted is traditional non-clinical performance testing for a physical product.
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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: K222720
Trade/Device Name: Blue 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 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) K222720
Device Name BLUE 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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K222720 510(k) SUMMARY
This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR 870.92.
| 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 | : | 18 Nov 2022 |
2.0 ldentification of the subject device:
| Trade Name: | Blue 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:
K192333
Trade name: Blue Nitrile Examination Gloves Powder Free Company: JR Engineering and Medical Technologies (M) Sdn Bhd
4.0 Description of The Subject Device:
Blue 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 with the predicate Device:
The Blue Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319or equivalent standards as shown in Table
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Table 1
| STANDARDS | DEVICE PERFORMANCE | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CHARACTERISTICS | PREDICATE | CURRENT | COMPARISONANALYSIS | ||||||||||||||||||||||||||||||||||||
| BLUE | BLUE | ||||||||||||||||||||||||||||||||||||||
| 510(k) Number | - | K192333 | K222720 | ||||||||||||||||||||||||||||||||||||
| Manufacturer(s) | - | JR Engineering & Medical Technologies(M) Sdn Bhd. | Safeskin Retailing (HK) Limited | ||||||||||||||||||||||||||||||||||||
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |||||||||||||||||||||||||||||||||||
| Color | - | Blue | Blue | Same | |||||||||||||||||||||||||||||||||||
| Sterility | - | Non-Sterile | Non-Sterile | Same | Handedness | - | Ambidextrous | Ambidextrous | Same | Product Code | - | LZA | LZA | Same | Physical Properties | ASTM D6319 | Before AgingTensile Strength:Ultimate Elongation: | 25.6Mpa868% | 28.0 – 32.8 Mpa530 – 590 % | Different butwithin the ASTMstandard | After Aging TensileStrength:Ultimate Elongation: | 22.0Mpa828% | 30.9 – 35.1 Mpa460 - 540% | Different but within theASTMstandard | Thickness:- FingerPalm | ASTM D6319 | 0.22mm0.20mm | 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 | 0.21mg/glove | Below 2mg of residual powder | Different butwithin the ASTMstandard | |||||
| Handedness | - | Ambidextrous | Ambidextrous | Same | |||||||||||||||||||||||||||||||||||
| Product Code | - | LZA | LZA | Same | |||||||||||||||||||||||||||||||||||
| Physical Properties | ASTM D6319 | ||||||||||||||||||||||||||||||||||||||
| Before AgingTensile Strength:Ultimate Elongation: | 25.6Mpa868% | 28.0 – 32.8 Mpa530 – 590 % | Different butwithin the ASTMstandard | ||||||||||||||||||||||||||||||||||||
| After Aging TensileStrength:Ultimate Elongation: | 22.0Mpa828% | 30.9 – 35.1 Mpa460 - 540% | Different but within theASTMstandard | ||||||||||||||||||||||||||||||||||||
| Thickness:- FingerPalm | ASTM D6319 | 0.22mm0.20mm | 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 | 0.21mg/glove | Below 2mg of residual powder | Different butwithin the ASTMstandard |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRENTBLUE | |||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the condition of study notan irritant | 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 condition of thestudy not a sensitizer | Under conditions of this study,thetest material did not produce a skinsensitization effect in the guineapigs. | Same | |
| Acute SystemicToxicity, ISO 10993-11:2017 (E) | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern | Under conditions of this study,thetest item did not induce anysystemic toxicity in Swiss albinomice. | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Watertight (1000ml) | ASTM D5151:2019 | Gloves passes AQL 1.5 | Meets● 21 CFR 800.20● ASTM D6319-10(Reapproved 2015)Tested in accordance with ASTMD5151 (Reapproved 2015) withacceptable results at an AQL 1.5 | Different but within theASTM standard. |
| Intended use | – | JR MEDIC BLUE Nitrile ExaminationGloves Powder Free is disposabledevices intended for medicalpurpose that are worn on theexaminers hand to preventcontamination between patient andexaminer | A Nitrile patient examination glove is adisposable device made of nitrilerubber intended for medical purposesthat is worn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical Glove GuidanceManual —Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical Glove GuidanceManual —Labeling | Single Use | Single Use | Same |
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7.0 Summary of Non-Clinical Testing
| 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 | Pass |
| Min 14.0MPa | Min 14.0MPa | XS - 28.1S - 28.4M - 29.2L - 28.0XL - 28.9 | XS - 31.2S – 30.9M - 32.3L - 31.0XL - 31.3 | |||||
| Ultimateelongation | Min500% | Min400% | XS - 540S - 530M - 550L - 540XL - 540 | XS - 460S – 460M - 470L - 490XL - 480 | Pass |
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below:
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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 0.05mm | Thickness0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | ||||||
| Small | LengthMin 240 mm | Length242 mm | Pass | ||||
| Width$80 \pm 10$ mm | Width85.0 mm | Pass | |||||
| ThicknessFinger – min 0.05mm | Thickness0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | ||||||
| Medium | LengthMin 240 mm | Length242 mm | Pass | ||||
| Width$95 \pm 10$ mm | Width95.0 mm | Pass | |||||
| ThicknessFinger – min 0.05mm | Thickness0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.06 mm | ||||||
| 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 | |||
| X-Large | Length | Min 240 mm | Length | 244 mm | Pass | ||
| Width | $120 \pm 10$ mm | Width | 115 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 this samplingis 150,001 to500,000. Hence,according to the singlesamplingplan GI, the sample to be drawnisunder code M equivalent to315 pieces with accept 10 andreject 11 to be accepted underAQL 1.5.For Size XS, during the test,4piece was found with leaks.Hence it falls within theacceptance criteria.For Size S. during the test,2piece was found with leaks.Hence it falls within theacceptance criteria.For Size M, during the test,3piece was found with leaks.Hence it falls within theacceptance criteria.For Size L, during the test,1piece was foundwith leaks. Hence it fallswithin the acceptancecriteria.For Size XL, during thetest, 2piece 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 size : 5 pcsResult XS : 0.30mg/gloveResult S : 0.26mg/gloveResult M : 0.34mg/gloveResult L : 0.38mg/gloveResult XL : 0.40mg/glove | Pass |
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8.0 Non-clinical performance testing methods full titles:
Non-Clinical Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:
- ASTM D6319-10 Standard D6319-10 Standard Specification for Nitrile Examination Gloves o for Medical Application
- ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and O Thermoplastic Elastomers-Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an o Air Oven
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions O
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in o Medical Gloves
- O ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes O
- ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and o Sensitization
- ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity ೧
9.0 Summary of Clinical Testing:
No clinical studies were conducted for either the subject or predict glove.
10.0 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, "Blue 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 K192333.
§ 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.