(192 days)
A 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. These gloves are designed for single use only and should be disposed after use.
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface 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 on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
The provided document describes the acceptance criteria and results of a study for the "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" (K212916).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|
| Physical Properties | |||
| Tensile Strength (Before aging) | Min 14.0 MPa | 30.9 Mpa | Pass |
| Tensile Strength (After aging) | Min 14.0 MPa | 34.2 Mpa | Pass |
| Ultimate Elongation (Before aging) | Min 500% | 583% | Pass |
| Ultimate Elongation (After aging) | Min 400% | 538% | Pass |
| Watertight | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | 0 pieces with leaks (for a batch size of 150,001 to 500,000, where 315 pcs were drawn for testing). | Pass |
| Dimension (Length) | Min 240 mm (for all sizes) | X-Small: 251 mm, Small: 250 mm, Medium: 251 mm, Large: 250 mm, X-Large: 249 mm | Pass |
| Dimension (Palm Width) | X-Small: 70 ± 10 mm, Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, X-Large: 120 ± 10 mm | X-Small: 78.0 mm, Small: 88.0 mm, Medium: 98.0 mm, Large: 108 mm, X-Large: 118 mm | Pass |
| Dimension (Thickness - Finger) | Min 0.05 mm | 0.10 mm (for all sizes) | Pass |
| Dimension (Thickness - Palm) | Min 0.05 mm | 0.07 mm (for all sizes) | Pass |
| Residual Powder | Less than 2 mg per glove | 0.20 mg/glove (Sample size: 5 pcs) | Pass |
| Biocompatibility - Primary Skin Irritation | "Passes" (Predicate result), "Negligible" irritant response (Subject device) | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'. | Similar |
| Biocompatibility - Dermal Sensitization | "Passes" (Predicate result), "No skin sensitization effect" (Subject device) | The test material did not produce a skin sensitization effect in the guinea pigs. | Similar |
| Biocompatibility - Cytotoxicity | "Passes" (Predicate result) | The test material demonstrated a cytotoxic effect under the condition of this study. Grade 2 for 6.25% & 12.5%, Grade 4 for 25%, 50% & 100%. (Note: Additional test i.e. Acute Systemic Toxicity was tested, indicating a deviation from the predicate's implied acceptance but mitigated by further testing) | Different (But additional test performed) |
| Biocompatibility - Acute Systemic Toxicity | Not Applicable (Predicate result) | The test item did not induce any systemic toxicity in Swiss albino mice. | Different |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical Properties: The document doesn't explicitly state the sample size for individual physical properties tests, but generally refers to conforming to ASTM D412.
- Watertight: The sample size for the watertight test was 315 pieces from a batch size of 150,001 to 500,000.
- Dimension: The document doesn't specify a sample size for dimensional measurements per glove size, but mentions measurement as per ASTM D6319.
- Residual Powder: The sample size for residual powder was 5 pieces.
- Biocompatibility: The sample size for biocompatibility tests is not explicitly stated in the provided text for each specific test, but they generally follow ISO and CPSC standards, which would define appropriate sample sizes for these types of biological evaluations. For Dermal Sensitization, "guinea pigs" are mentioned, and for Acute Systemic Toxicity, "Swiss albino mice" are mentioned, implying animal testing was conducted.
The data provenance is not explicitly stated as "retrospective" or "prospective." However, given that this is a 510(k) submission for a new device claiming substantial equivalence to a predicate, the tests are conducted on the subject device (K212916) in order to demonstrate its performance. The manufacturer, Rimba Glove Sdn Bhd, is located in Perak, Malaysia. The testing would have been conducted to support this submission.
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 device is a patient examination glove, a non-AI/software medical device. Therefore, the concept of "ground truth established by experts" in the context of diagnostic interpretation (like in imaging AI) is not applicable here. The "ground truth" for the performance tests (e.g., tensile strength, watertightness, dimensions, powder content, biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO), and the results are quantifiable measurements or observed biological responses as determined by standard laboratory practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving human interpretation that would require adjudication. The test methods are objective, standardized laboratory measurements and biological assays.
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 a physical medical device (examination glove) and does not involve human readers, AI, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., ASTM D412, D5151, D3767, D6124, D6319) and ISO (e.g., ISO 10993 for biocompatibility).
- Quantifiable Measurements: Physical properties (tensile strength, elongation, dimensions, powder residue) are measured directly.
- Biological Responses: Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are assessed based on scientific protocols for animal and in vitro tests, adhering to ISO 10993 and CPSC guidelines.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, no ground truth was established for it.
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March 24, 2022
Rimba Glove SDN BHD % Michael Woude U. S agent Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
Re: K212916
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: February 13, 2022 Received: February 22, 2022
Dear Michael Woude:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For BiFeng Oian, Ph.D. Acting 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) K212916
Device Name BLACK NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE
Indications for Use (Describe)
A 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. These gloves are designed for single use only and should be disposed after use.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Sponsor:
2.0
| Company Name | : Rimba Glove Sdn Bhd |
|---|---|
| Company Address | : Plot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh,Perak, Malaysia. |
| Submitter: | |
| Name | : Zahari Bin Darus |
| Address | : Rimba Glove Sdn BhdPlot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh, Perak,Malaysia. |
Date of Summary Prepared: 20th Aug 2021 (Revised date: 23rd March 2022)
3.0 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:
Phone No.
Fax No.
K190942
Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.
: +605-5483688
: +605-5481688
4.0 Description of The Device:
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface 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 on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
| Design | : Ambidextrous (i.e. fit either hand) |
|---|---|
| Colour | : Black. |
| Intended use | : Single Use and Non-Sterile |
| Finishing | : Finger Textured. |
| Performance | : See Section 7 – Summary of Non-Clinical Testing |
| Storage | : The product is kept away from direct sunlight and fluorescentlighting and stored in an environment with temperature notexceeding 40 degree C. |
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Indication for use:
A 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. These gloves are designed for single use only and should be disposed after use.
Information for "Powder Free" Claim:
The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).
Glove Size and dimension:
Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.
| Size | Palm Width (mm) | Length (mm) |
|---|---|---|
| X-Small | 70±10 | Minimum 240 |
| Small | 80+10 | Minimum 240 |
| Medium | 95+10 | Minimum 240 |
| Large | 110±10 | Minimum 240 |
| X-Large | 120±10 | Minimum 240 |
5.0 Technological Characteristics Comparison of the Device:
Provided below is the technological comparison of the subject device vs the predicate device as shown in Table 1.
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLACK | SUBJECT DEVICEBLACK | |||
| 510(k) Number | - | K190942 | K212916 | |
| Manufacturer(s) | - | Ever Growth EnterpriseCorporation | Rimba Glove Sdn Bhd | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Class | - | Class 1 | Class 1 | Same |
| Product Code | - | LZA | LZA | Same |
| Regulation | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Physical PropertiesBefore AgingTensile Strength:Ultimate Elongation:After AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 14Mpa, min500% min14Mpa, min400% min | 30.9Mpa583%34.2Mpa538% | Different but withinthe ASTM standardDifferent but withinthe ASTM standard |
| Physical Dimension:Thickness:- Finger- Palm- Glove Length- Palm Width | ASTM D6319 | 0.05mm min0.05mm min>230mmX Small :70 $\pm$ 10mmSmall :80 $\pm$ 10mmMedium :95 $\pm$ 10mmLarge :110 $\pm$ 10mmX Large :120 $\pm$ 10mm | 0.10mm0.07mm>240mmX Small :70 $\pm$ 10mmSmall :80 $\pm$ 10mmMedium :95 $\pm$ 10mmLarge :110 $\pm$ 10mmX Large :120 $\pm$ 10mm | Different but withinthe ASTM standardSame |
| Powder Free | ASTM D6124 | < 2mg per glove | 0.20 mg/glove | Different but within the ASTM standard |
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| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISONANALYSIS |
| BLACK | BLACK | |||
| Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Passes | The test material did not causean irritant response. ThePrimary Irritant ResponseCategory is deemed 'Negligible' | Similar | |
| Biocompatibility | Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Passes | The test material did notproduce a skin sensitizationeffect in the guinea pigs. | Similar |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Passes | The test material demonstrateda cytotoxic effect under thecondition of this study.Grade 2 for 6.25% & 12.5%Grade 4 for 25%, 50% & 100%Additional test i.e. AcuteSystemic Toxicity was tested. | Different – butadditional test ofAcute SystemicToxicity isconducted. | |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISONANALYSIS |
| BLACK | BLACK | |||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Applicable | The test item did not induceany systemic toxicity in Swissalbino mice. | Different. |
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTMD6319-10 and ASTM D5151-06(reapproved 2011), G-1, AQL2.5 | Gloves passed AQL 1.5 | Different, butwithin the ASTMstandard. |
| Intended use /Indications for use | - | The Nitrile Powder Free patientexamination glove is a non-sterile disposable deviceintended for medical purposethat is worn on the examiner'shands or finger to preventcontamination between patientand examiner. | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical GloveGuidance Manual -Labeling | X SmallSmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual -Labeling | Yes | Single Use | Same |
| Sterility Status | Medical GloveGuidance Manual -Labeling | Non-Sterile | Non-Sterile | Same |
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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.
6.0 Summary of Non-Clinical Testing
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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| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| Physical Properties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0 MPa | Min 14.0 MPa | 30.9Mpa | 34.2Mpa | Pass |
| Ultimateelongation | Min 500% | Min 400% | 583% | 538% | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise 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 Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 0piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber-Measurementof Dimensions | To measure thelength, width andthicknessofglove | X-Small | Length | Min 240 mm | Length | 251 mm | Pass |
| Width | $70 \pm 10$ mm | Width | 78.0 mm | Pass | ||||
| Thickness | Finger - min 0.05mm | Thickness | 0.10 mm | Pass | ||||
| Palm - min 0.05mm | 0.07 mm | |||||||
| Small | Length | Min 240 mm | Length | 250 mm | Pass | |||
| Width | $80 \pm 10$ mm | Width | 88.0 mm | |||||
| Thickness | Finger - min 0.05mm | Thickness | 0.10 mm | |||||
| Palm - min 0.05mm | 0.07 mm | |||||||
| Medium | Length | Min 240 mm | Length | 251 mm | Pass | |||
| Width | $95 \pm 10$ mm | Width | 98.0 mm | |||||
| Thickness | Finger - min 0.05mm | Thickness | 0.10 mm | |||||
| Palm - min 0.05mm | 0.07 mm | |||||||
| Large | Length | Min 240 mm | Length | 250 mm | Pass | |||
| Width | $110 \pm 10$ mm | Width | 108 mm | Pass | ||||
| Thickness | Finger - min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass | ||||
| Length | Min 240 mm | Length | 249 mm | Pass | ||||
| X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass | |||
| Thickness | Finger - min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult :0.20mg/glove | Pass |
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| Biocompatibility Testing Information | ||||
|---|---|---|---|---|
| Standard | Primary Skin Irritation – ISO10993-10:2010 (E) &Consumer Product SafetyCommission Title 16. ChapterII, Part 1500 | Dermal Sensitization- ISO10993-10: 2010 (E) &Consumer Product SafetyCommission, Title 16, ChapterII, Part 1500.3 (c) (4) | Cytotoxicity - MEM Elution,ISO 10993-5: 2009 (E) | Acute Systemic Toxicity,ISO 10993-11:2017 (E) |
| Results | The test material did notcause an irritant response.The Primary Irritant ResponseCategory is deemed'Negligible' | The test material did notproduce a skin sensitizationeffect in the guinea pigs. | The test materialdemonstrated a cytotoxiceffect under the conditionof this study.Grade 2 for 6.25% &12.5%Grade 4 for 25%, 50% &100%Additional test i.e. AcuteSystemic Toxicity wastested. | The test item did notinduce any systemictoxicity in Swiss albinomice. |
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject 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 devices 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.