(190 days)
Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.
The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, Powder Free. It demonstrates the substantial equivalence of the proposed device to a legally marketed predicate device (Primus Nitrile Examination Gloves, K143477).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nitrile Patient Examination Gloves, Powder Free (Lalan Rubbers (Pvt) Ltd)
| Characteristic | Acceptance Criteria (Predicate Device / ASTM D6319) | Reported Device Performance (Nitrile Patient Examination Gloves, Powder Free) |
|---|---|---|
| Physical Characteristics: | ASTM D6319 requirements | Meets ASTM D6319 requirements |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (XS) | $70 \pm 10$ | $\leq 80$ |
| Palm width (S) | $80 \pm 10$ | $85 \pm 5$ |
| Palm width (M) | $95 \pm 10$ | $95 \pm 5$ |
| Palm width (L) | $110 \pm 10$ | $105 \pm 5$ |
| Palm width (XL) | $120 \pm 10$ | $\geq 110$ |
| Thickness (Finger) | Minimum 0.05mm | $0.09 \pm 0.01$mm |
| Thickness (Palm) | Minimum 0.05mm | $0.07 \pm 0.01$mm |
| Thickness (Cuff) | Not explicitly defined (implied by ASTM) | $0.05 \pm 0.01$mm |
| Physical Properties: | ASTM D6319 requirements for tensile strength and ultimate elongation | Meets ASTM D6319 requirements |
| Tensile Strength (Before Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Tensile Strength (After Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Ultimate Elongation (Before Aging) | Minimum 500% | Minimum 500% |
| Ultimate Elongation (After Aging) | Minimum 400% | Minimum 400% |
| Freedom from holes: | ASTM D6319 requirements of GI, AQL 2.5 | Meets ASTM D6319 and ASTM D5151 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319 requirements; Not more than 2.0mg/glove | Meets applicable requirement for powder free; $\leq$ 2 mg per glove |
| Biocompatibility: | ASTM and ISO standards | - |
| Skin Irritation Test | Not an irritant (Under predicate study conditions) | Under the conditions of the study, not an irritant (ISO10993-23:2021) |
| Skin Sensitization Test | Not a sensitizer (Under predicate study conditions) | Under the conditions of the study, not a sensitizer (ISO 10993-10:2010) |
| In Vitro Cytotoxicity | Not explicitly stated for predicate | Diluted concentrations 12.5% and 6.25% are not cytotoxic. Undiluted extract (100%), diluted concentrations 50% & 25% are cytotoxic. (ISO 10993-5:2009) |
| Acute Systemic Toxicity | Not explicitly stated for predicate | Under the conditions of the study, no evidence of systemic toxicity (ISO 10993-11: 2017) |
| Shelf Life | 3 years | 3 years (EN, 455-4:2009) |
2. Sample size used for the test set and the data provenance
The document specifies that non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The sample sizes for each specific test (e.g., number of gloves for physical testing, number of samples for biocompatibility) are not explicitly provided in this summary document. However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes and methodologies.
The "data provenance" (country of origin, retrospective/prospective) is not detailed for the test samples, but the tests were performed by Lalan Rubbers (Pvt) Ltd in Sri Lanka, which is the manufacturer. The tests are prospective in nature, as they involve testing newly manufactured devices against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device (Nitrile Patient Examination Gloves) does not involve expert interpretation or clinical diagnosis that would require human "ground truth" establishment in the typical sense of AI/clinical decision support systems. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM D6319, ISO 10993 series). Therefore, there were no "experts" establishing a subjective ground truth for a test set in this context. The acceptance criteria are quantitative and based on published standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is objective measurement against established physical and chemical standards. There is no subjective interpretation requiring adjudication.
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 device is a medical glove, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are for the physical, chemical, and biological properties of the glove itself.
7. The type of ground truth used
The ground truth used for this device's performance evaluation against acceptance criteria is objective measurement against recognized international standards and specifications. Specifically:
- Physical and Dimensional Properties: ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- Freedom from holes: ASTM D6319 and ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Powder Residual: ASTM D6319 and ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Biocompatibility: ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 10993-5 (Biological evaluation of medical devices for irritation, sensitization, systemic toxicity, and cytotoxicity)
- Shelf Life: EN 455-4:2009 (Medical gloves for single use Part 4: Requirements and testing for shelf life determination)
8. The sample size for the training set
Not applicable. This product is not an AI/machine learning model, so there is no concept of a "training set" in this context. The design and manufacturing process for the gloves are developed based on general engineering and material science principles, and then verified through the non-clinical tests mentioned.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
September 15, 2022
Lalan Rubbers (Pvt) Ltd Renuka Priyangi Manager - Quality Assurance No.95/B, Zone A, Export Processing Zone, Biyagama Malwana, Western EPZ 11672 Sri Lanka
Re: K220697
Trade/Device Name: Nitrile Patient Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 29, 2022 Received: August 26, 2022
Dear Renuka Priyangi:
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,
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) K220697
Device Name
Nitrile Patient Examination Gloves, Powder Free
Indications for Use (Describe)
Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands 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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510(k) Summary K220697
APPLICANT
| Company Name | Lalan Rubbers (Pvt) Ltd |
|---|---|
| Address | No.95/B, Zone A, Export Processing Zone, Biyagama, MalwanaSri Lanka, EPZ 11672 |
CONTACT PERSON
| Name | Renuka Priyangi |
|---|---|
| Designation | Manager - QA |
| Telephone | 0094716852746 |
| Fax | 0094114311222 |
| qa@lalangroup.com |
DATE PREPARED September 15, 2022
DEVICE
| Trade Name | Nitrile Patient Examination Gloves, Powder Free |
|---|---|
| Common Name | Nitrile Patient Examination Gloves |
| Classification | Nitrile Patient Examination Gloves |
| Product Code | LZA |
| Device Class | Class I |
| C.F.R. Section | 21 CFR 880.6250 |
| Classification Panel | General Hospital |
LEGALLY MARKETED PREDICATE DEVICE
| Product Owner | Primus Gloves Private Limited |
|---|---|
| Trade name | Primus Nitrile Examination Gloves |
| 510(k) Number | K143477 |
| Device Class | Class I |
| Product code | LZA |
DEVICE DESCRIPTION
The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.
Characteristic
| Sterility | Non Sterile |
|---|---|
| Material | Nitrile |
| Surface treatment | Inner chlorinated outer polymer coated |
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| Color | Blue |
|---|---|
| Geometry | Ambidextrous |
| Texture | Full textured |
| Cuff end finishing | Beaded |
| Usage | Single use & Over-the counter |
| Target Population | Adults |
| Available sizes | Ex Small, Small , Medium , Large, Ex Large |
| Shelf life | 3 Years |
INDICATIONS FOR USE STATEMENT
Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Predicate Device | Proposed SubjectDevice | ComparisonResult | |
|---|---|---|---|
| Trade name | Primus NitrileExamination Gloves | Nitrile PatientExamination Gloves,Powder Free | Notapplicable |
| 510k Number | K143477 | K220697 | NotApplicable |
| Product Owner | Primus Gloves PrivateLimited | Lalan Rubbers (Pvt) Ltd | NotApplicable |
| Product Code | LZA | LZA | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Regulatory Class | 1 | 1 | Same |
| Regulation Name | Patient ExaminationGlove | Patient ExaminationGlove | Same |
| Classification Panel | General Hospital | General Hospital | Same |
| Target Population | Adults | Adults | Same |
| Intended Use/Indications for Use | The Nitrile PatientExamination gloves,Powder free, Blue color, is adisposable device intendedfor medical purposes that isworn on the examiners'hand or finger to preventcontamination betweenpatient and examiner. | Nitrile PatientExamination Gloves,Powder Free, areintended for medicalpurposes that are wornon the examiners' handsto prevent contaminationbetween patient andexaminer. | Same |
| MaterialComposition | Synthetic nitrile rubber | Synthetic nitrile rubber | Same |
| Design | Non-sterile | Non-sterile | Same |
| Single use | Single use | Same | |
| Powder-free | Powder-free | Same |
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| Ambidextrous | Ambidextrous | Same | ||
|---|---|---|---|---|
| Beaded cuff | Beaded cuff | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | |
| Shelf Life | 3 years | 3 years | Same | |
| Performancea. Dimensions | Meets ASTM D6319requirements | Meets ASTM D6319requirements | Same | |
| b. Physical Properties | Meets ASTM D6319requirements | Meets ASTM D6319requirements | Same | |
| c. Freedom from holes | Meets ASTM D6319requirements of GI, AQL2.5 | Meets ASTM D6319requirements of GI, AQL2.5 | Same | |
| d. Powder Residual | Meets ASTM D6319requirements; Not morethan 2.0mg/glove | Meets ASTM D6319requirements; Not morethan 2.0mg/glove | Same | |
| e. Sterility | Non-sterile | Non-sterile | Same | |
| Biocompatibility | Skin Irritation | Under the conditions of thestudy not an irritant | Under the conditions ofthe study not an irritant | Same |
| SkinSensitization | Under the conditions of thestudy not a sensitizer | Under the conditions ofthe study not a sensitizer | Same | |
| In VitroCytotoxicity | No data available | Under the conditions ofthe study for dilutedconcentrations 12.5% and6.25% are not cytotoxic.Undiluted extract (100%),diluted concentrations50% & 25% arecytotoxic. | Similar | |
| AcuteSystemicToxicity | No data available | Under the conditions ofthe study no evidence ofsystemic toxicity | Similar |
DISCUSSION OF NON-CLINICAL TESTS PERFORMED
Non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The test results demonstrated that the proposed subject device complies with the following standards:
- ASTM, D6319-19, Standard Specification for Nitrile Examination Gloves for Medical । Application
- -ASTM, D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM, D5151-19, Standard Test Method for Detection of Holes in Medical Gloves -
- ISO, 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices Part 10: -Tests for irritation and skin sensitization
- ISO,10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation
- ISO,10993-11 Third edition 2017-09, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
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- ISO,10993-5 Third edition 2009-06-01, Biological evaluation of medical devices Part 5: -Tests for in vitro cytotoxicity
- EN, 455-4:2009, Medical gloves for single use Part 4: Requirements and testing for shelf life determination
| Characteristics | Standard/Specification | Result Summary |
|---|---|---|
| 1. Physical Characteristics: | ||
| 1.1 Dimensions | ASTM D6319 | Meets ASTM D6319 requirements forlength, palm width and thickness |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (mm) | ||
| Size - XS | $70 \pm 10$ | $\leq 80$ |
| Size - S | $80 \pm 10$ | $85\pm5$ |
| Size - M | $95 \pm 10$ | $95\pm5$ |
| Size - L | $110\pm 10$ | $105\pm5$ |
| Size - XL | $120 \pm 10$ | $\geq 110$ |
| Thickness (mm) - single-wall | ||
| Finger | minimum 0.05 | Finger - $0.09 \pm 0.01$ |
| Palm | minimum 0.05 | Palm - $0.07 \pm 0.01$ |
| Cuff | - | Cuff - $0.05 \pm 0.01$ |
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Image /page/7/Picture/0 description: The image shows the logo for Lalan Rubbers. The logo consists of a stylized symbol in blue and green, resembling a curved or flowing shape. To the right of the symbol is the word "LALAN" in bold, dark blue letters. Below "LALAN" is the word "Rubbers" in a smaller, lighter font.
| 1.2 PhysicalProperties | ASTM D6319 | Meets ASTM D6319 requirements fortensile strength and ultimateelongation before and afteraccelerated aging |
|---|---|---|
| Tensile Strength | ||
| Before Aging | minimum 14 MPa | minimum 14 MPa |
| After Aging | minimum 14 MPa | minimum 14 MPa |
| Ultimate Elongation | ||
| Before Aging | minimum 500% | minimum 500% |
| After Aging | minimum 400% | minimum 400% |
| 2. Freedom fromholes | ASTM D6319ASTM D5151 | Meets ASTM D6319 and ASTM D5151requirements of AQL 2.5 |
| 3. Powder Residual | ASTM D6319ASTM D6124 | Meets applicable requirement for powderfree; ≤ 2 mg per glove |
| 4. Biocompatibility | ||
| Skin IrritationTest | ISO10993-23:2021 | Under the conditions of the study, not anirritant |
| Skin Sensitization Test(GPMT) | ISO 10993-10:2010 | Under the conditions of the study, not asensitizer |
| In VitroCytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, dilutedconcentrations 12.5% and 6.25% are notcytotoxic. Undiluted extract (100%),diluted concentrations 50% & 25% arecytotoxic. |
| Acute SystemicToxicity | ISO 10993-11: 2017 | Under the conditions of the study, noevidence of systemic toxicity |
DISCUSSION OF CLINICAL TESTS PERFORMED
Clinical testing is not needed for this device.
CONCLUSION
The conclusions drawn from the non-clinical tests demonstrate that Nitrile Patient Examination Gloves, Powder Free is as safe as effective, and performs as well as or better than the legally marketed predicate device previously cleared under K143477.
§ 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.