(25 days)
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use and single use only. The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene. The device does not incorporate powder for purpose other than manufacturing. The final finished glove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process. The device is provided non-sterile.
This document is a 510(k) Premarket Notification for a medical device: "Powder-Free Nitrile Examination Glove, Non-Sterile". It demonstrates the device's substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Important Note: This document is about a Class I medical device (examination gloves). For such devices, clinical studies (MRMC, algorithm-only performance, etc.) are generally not required, and the "ground truth" often refers to well-established physical and chemical standards rather than diagnostic outcomes. This is explicitly stated in Section 5.0: "Clinical testing is not needed for this device and review."
Therefore, many of the typical questions for AI/diagnostic devices regarding MRMC, standalone performance, and complex ground truth establishment are not applicable here. The focus is on demonstrating that the new glove meets existing performance standards and is biocompatible.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by the ASTM (American Society for Testing and Materials) standards referenced, and the device performance is reported against these.
| Characteristic | Standard/Test Method | Purpose of Testing | Acceptance Criteria (Predicate/Guidance) | Reported Device Performance (CURRENT) | Status |
|---|---|---|---|---|---|
| Physical Properties | To evaluate the tensile (tension) properties of glove. | ||||
| Tensile Strength (Before Aging) | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | Min 14.0 MPa (New Device) / 28 MPa min (Predicate) | 14.0 MPa | Pass | |
| Ultimate Elongation (Before Aging) | ASTM D412 | Min 500% (New Device) / 500% min (Predicate) | Min 500% | Pass | |
| Tensile Strength (After Aging) | ASTM D412 | Min 14.0 MPa (New Device) / 30 MPa min (Predicate) | 14.0 MPa | Pass | |
| Ultimate Elongation (After Aging) | ASTM D412 | Min 400% (New Device) / 480% min (Predicate) | Min 400% | Pass | |
| Dimensions | ASTM D3767 (Standard Practice for Rubber—Measurement of Dimensions) | To measure the length, width and thickness of glove. | |||
| Length | Min 230 mm | Min 230 mm | Pass | ||
| Width | Min 95 ± 10 mm | Min 95 ± 10 mm | Pass | ||
| Thickness (Finger) | 0.05 mm (New Device) / 0.10 mm (Predicate) | 0.05 mm | Pass | ||
| Thickness (Palm) | 0.05 mm (New Device) / 0.06 mm (Predicate) | 0.05 mm | Pass | ||
| Thickness (Cuff) | NA / 0.04 mm (Predicate) | NA | Pass | ||
| Powder Free | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove | 1.2 mg/glove (Sample size: 5 pcs) | Pass |
| Biocompatibility | |||||
| Skin Sensitization | Dermal Sensitization - ISO 10993-10: 2010 (E) | To determine whether the subject device is a sensitizer. | Magnusson and Kligman grades of less than 1 | Non-Sensitizer to Guinea Pigs (0% sensitization rate) | Pass |
| Skin Irritation | Primary Skin Irritation - ISO 10993-10:2010 (E) | To determine whether the subject device is an irritant. | Primary or Cumulative Irritation Index (PII) of 0.4 or less | Non-irritant in New Zealand White Rabbits | Pass |
| Cytotoxicity | Cytotoxicity - MEM Elution, ISO 10993-5: 2009 (E) | To determine whether the subject device is cytotoxic. | Reactivity grade should not be greater than grade 2 or should show "mild reactivity". | Non-Cytotoxic on Hela Cells | Pass |
| Acute Systemic Toxicity | Acute Systemic Toxicity, ISO 10993-11:2017 (E) | To determine whether the subject device causes a systemic response. | 1. No animals showed significantly greater biological reactivity than solvent control. 2. No body weight loss > 10%. 3. No mortality or abnormal behavior. | Does not induce any systemic toxicity in Swiss albino mice | Pass |
| Watertight | ASTM D5151:2019 | (Implied: To ensure barrier integrity) | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Residual Powder Test Set Sample Size: 5 pieces (stated for the ASTM D6124 test).
- Other tests: Specific sample sizes for each physical properties and biocompatibility test are not explicitly detailed (e.g., how many gloves for tensile strength, or how many animals for biocompatibility tests), but the mention of standards like ASTM and ISO implies that standard sample sizes for those tests were used.
- Data Provenance: The tests are non-clinical bench performance tests. The specific geographic origin of the lab conducting the tests is not stated, but the company is "GoodGloves Industries Sdn Bhd" located in Malaysia. The tests are retrospective, conducted to demonstrate equivalence for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable in the context of this device and study. "Ground truth" for examination gloves is established by objective, quantifiable physical and chemical tests defined by international standards (ASTM, ISO). There are no human experts subjectively interpreting outcomes for a "ground truth" label, as would be the case for diagnostic imaging.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. Clinical studies, including MRMC studies, are explicitly stated as "not needed for this device and review" (Section 5.0).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is not an algorithm or AI system. It is a physical medical device (glove).
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on established international performance standards (ASTM, ISO) for physical properties (tensile strength, elongation, dimensions, watertightness, residual powder) and biocompatibility testing (skin sensitization, skin irritation, cytotoxicity, acute systemic toxicity) on animal models or cell cultures, as defined by relevant ISO standards.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 23, 2022
GoodGloves Industries Sdn Bhd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K221877
Trade/Device Name: Powder-Free Nitrile 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: June 27, 2022 Received: June 28, 2022
Dear Prithul Bom:
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.
Clarence W. Murray, III, PhD 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) K221877
Device Name
Powder Free Nitrile Examination Glove, Non Sterile
Indications for Use (Describe)
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY - K221877
1.0 Submitter:
| Name: | Yee Kam Lin |
|---|---|
| Address: | GoodGloves Industries Sdn BhdPT 12678, Jalan Techvalley 2, Sendayan Techvalley, BandarSri Sendayan, 71950 Seremban, Negeri Sembilan, Malaysia |
| Phone No.: | 06-781 8888 |
Date of Summary Prepared: July 21, 2022
2.0 Device Description
| Common Name | : | Powder-Free Nitrile Examination Gloves |
|---|---|---|
| Trade/ProprietaryName | : | Powder Free Nitrile Examination Glove, Non-Sterile |
| Device Classification | : | Class I |
| ClassificationRegulation | : | 21 CFR 880.6250 (Non-Powdered Patient ExaminationGlove) |
| Product Code | : | LZA (Polymer Patient Examination Glove) |
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use and single use only.
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene.
The device does not incorporate powder for purpose other than manufacturing. The final finished alove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process.
The device is provided non-sterile.
3.0 Summary of the Technological Characteristics Comparison of the device:
The Powder Free Nitrile Examination Glove, Non-Sterile, meets minimal thickness of 0.06 mm and minimal length of 230 mm respectively.
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Non-Clinical Bench Performance Testing Comparison
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| 510(k) Number | - | K192333 | - | - |
| Manufacturer(s) | - | JR Engineering & MedicalTechnologies (M) SDN.BHD. | Goodgloves Industries Sdn Bhd | - |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Physical Properties | ASTM D6319 | Meets | Meets | |
| Before AgingTensile Strength:Ultimate Elongation: | 28Mpa min500% min | 14.00 MPa min500% min | Different butwithin the ASTMstandard | |
| After AgingTensile Strength:Ultimate Elongation: | 30Mpa min480% min | 14.00 MPa min400% min | Different butwithin the ASTMstandard | |
| Thickness :- Finger- Palm- Cuff | ASTM D6319 | 0.10mm0.06mm0.04mm | 0.05mm min0.05mm minNA | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Same |
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| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
|---|---|---|---|---|
| BLUE | BLUE | |||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Non Irritating | All animals were survived andno abnormal signs wereobserved during the study. | Similar |
| Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Non Sensitization | No skin sensitization reactionwas found in the skin of guineapig, and the positive rate ofsensitization was 0% | Similar | |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Non Cytotoxic | Findings suggest that the testsamples and control sample isnot toxic for cell growth. | Similar |
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| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| BLUE | BLUE | |||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Available | There was no evidence ofsystemic toxicity from theextract | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same |
| Intended use | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | Same | |
| Size | Medical GloveGuidance Manual –Labeling | X SmallSmallMediumLargeExtra Large | SmallMediumLargeExtra Large | Different |
| Single use | Medical GloveGuidance Manual –Labeling | Single use | Single use | Same |
There are no significant differences between the two products and are identical in terms of intended use, manufacturing methods except for size, physical properties and thickness. The current device is blue in color and thicker than predicate device.
4.0 Summary of Non-Clinical testing
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | 14.0MPa | 14.0 MPa | Pass |
| Ultimateelongation | Min500% | Min400% | Min 500% | Min 400% | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practice forRubber—Measurement ofDimensions | To measure thelength, width andthickness ofglove | LengthMin 230 mmWidthMin 95 ± 10 mmThicknessFinger – 0.05 mmPalm – 0.05 mmCuff - NA | LengthMin 230 mmWidthMin 95±10 mmThicknessFinger – 0.05 mmPalm – 0.05 mmCuff - NA | PassPassPass |
| Test Method | 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: 1.2 mg/glove | Pass |
| SkinSensitization | DermalSensitization- ISO10993-10: 2010 (E) | To determinewhether thesubject device is asensitizer. | Magnusson and Kligmangrades of less than 1 | Non- Sensitizer to GuineaPigs. | Pass |
| Skin Irritation | Primary SkinIrritation - ISO10993-10:2010 (E) | To determinewhether thesubject device isan irritant. | Primary or CumulativeIrritation Index (PII) of 0.4or less | Non-irritant in New ZealandWhite Rabbits | Pass |
| Cytotoxicity | Cytotoxicity - MEMElution, ISO 10993-5: 2009 (E) | To determinewhether thesubject device iscytotoxic. | Reactivity grade should notbe greater than grade 2 orshould show "mildreactivity". | Non-Cytotoxic on Hela Cells | Pass |
| Acute SystemicToxicity | Acute SystemicToxicity, ISO 10993-11:2017 (E) | To determinewhether thesubject devicecauses a systemicresponse. | 1. No animals showed asignificantly greaterbiological reactivity thananimals treated with solventcontrol.2. None showed body weightloss > 10%.3. No mortality or abnormalbehavior such as conclusionsor prostration occurred inthe control group animals. | Does not induce anysystemic toxicity in Swissalbino mice | Pass |
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5.0 Summary of Clinical Summary
Clinical testing is not needed for this device and review.
6.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Powder Free Nitrile Examination Gloves, Non Sterile, is as safe, as effective, and performs as well as or better than the legally marketed predicate devices 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.