(263 days)
Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This looks like a 510(k) Premarket Notification for a medical device (Black Pearl Nitrile Examination Glove). For this type of device, the acceptance criteria and supporting studies are focused on performance, safety, and biocompatibility, rather than clinical efficacy studies often seen with AI/ML devices.
Here's an analysis of the provided information, framed by your request:
Acceptance Criteria and Study for Black Pearl Nitrile Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the standards ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Applications) and ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves).
| Test Performed | Applicable Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Dimensions | ASTM D6319-19 | Length: XS, S: Min. 220mm; M, L, XL: Min. 230mm | Length: XS: Min. 242mm; S: Min. 244mm; M: Min. 241mm; L: Min. 240mm; XL: Min. 241mm | Pass |
| Width: XS: 70mm ±10mm; S: 80mm ±10mm; M: 95mm ±10mm; L: 110mm ±10mm; XL: 120mm ±10mm | Width: XS: 77-80mm; S: 83-86mm; M: 96-98mm; L: 107-110mm; XL: 119-124mm | Pass | ||
| Thickness: Palm - Min. 0.05mm; Finger - Min. 0.05mm | Thickness: Palm - Min. 0.06mm; Finger - Min. 0.08mm (for all sizes tested) | Pass | ||
| Freedom from Holes | ASTM D6319-19 | Sample size: 200 pcs, Inspection level: G-I, AQL: 2.5, Accept: ≤ 10 pieces, Reject: ≥ 11 pieces | 2 pieces were found with holes (within acceptance). | Pass |
| Physical Properties | ASTM D6319-19 | Before Aging: Tensile Strength: Min. 14 MPa; Ultimate Elongation: Min. 500%After Accelerated Aging: Tensile Strength: Min. 14 MPa; Ultimate Elongation: Min. 400% | Before Aging: Tensile Strength: Min. 18.2 MPa; Ultimate Elongation: Min. 500%After Accelerated Aging: Tensile Strength: Min. 17.4 MPa; Ultimate Elongation: Min. 400% | Pass |
| Powder-free Residue | ASTM D6124-06 (Reapproved 2017) | ≤ 2.0 mg/glove | 0.70 mg/glove | Pass |
| Skin Irritation Test | ISO 10993-23:2021(E) (Implied by conclusion) | Non-irritant | Primary irritation index obtained was '0'. No local skin irritation observed. | Pass |
| Skin Sensitization Test | ISO 10993-10:2010(E) (Implied by conclusion) | Non-sensitizer | No skin sensitization reactions observed. | Pass |
| In vitro Cytotoxicity | ISO 10993-5:2009 (Implied by conclusion) | Non-cytotoxic to L-929 cells in 1:16 dilution (6.25%) and 1:32 dilution (3.125%). Acceptably cytotoxic at higher concentrations/lower dilutions (undiluted, 1:2, 1:4, 1:8) for its classification as a surface device with limited contact. (This is a non-standard acceptance criteria interpretation for the table, as the report explicitly states cytotoxicity at higher concentrations). | Cytotoxic in undiluted (100%), 1:2 (50%), 1:4 (25%) and 1:8 dilution (12.5%). Non-cytotoxic to L-929 cells in 1:16 (6.25%) and 1:32 dilution (3.125%). | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) (Implied by conclusion) | Did not induce any acute systemic toxicity | Did not induce any acute systemic toxicity in swiss albino mice. No clinical toxicity or overt toxicity observed. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Dimensions: 13 pieces of gloves from each size (XS, S, M, L, XL) for each parameter (length, width, thickness). Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
- Freedom from Holes: 200 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of G-1 and AQL of 2.5.
- Physical Properties: 13 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
- Powder-free Residue: 5 pieces of gloves.
- Skin Irritation Test: 6 New Zealand White rabbits (3 for polar extracts, 3 for non-polar extracts).
- Skin Sensitization Test: 30 guinea pigs (5 for polar solvent control, 10 for polar test item extract, 5 for non-polar solvent control, 10 for non-polar test item extract).
- In vitro Cytotoxicity: L-929 mouse fibroblasts cells.
- Acute Systemic Toxicity Test: 20 Swiss Albino mice (4 groups of 5 males each).
Data Provenance: The document does not explicitly state the country of origin for the testing facilities or the specific animal vendors/data source, but the submitter is from Malaysia. These are prospective tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
These tests are standardized laboratory and in-vivo animal tests, not typically requiring "experts" in the sense of clinical reviewers establishing ground truth for diagnostic or AI systems. The "ground truth" is established by the well-defined and validated methodologies of the ASTM and ISO standards themselves. The results are quantitative measurements or qualitative observations by laboratory personnel trained in those specific methods.
4. Adjudication Method for the Test Set
Not applicable in the context of these types of performance and biocompatibility tests. Results are generally objective measurements or direct observations against a standard, not requiring multi-expert 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 an examination glove, not an AI/ML-based diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is based on:
- Standardized measurement protocols: For physical dimensions, tensile strength, elongation, and powder residue.
- Defined biological reactions: For freedom from holes (water leak detection) and biocompatibility tests (observed biological responses in animals or cell cultures according to ISO guidelines).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the typical sense. The performance characteristics of the glove are inherent to its manufacturing process and material properties, validated by testing against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 22, 2024
UG Global Resources Sdn. Bhd. Lee Mei Ling General Manager, OA Lot 62 & 63, Lorong Senawang 3/2, Kawasan Perindustrian Senawang, Seremban, Negeri Sembilan 70450 Malaysia
Re: K232319
Trade/Device Name: Black Pearl Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 12, 2024 Received: March 12, 2024
Dear Lee Mei Ling:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
{2}------------------------------------------------
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232319
Device Name Black Pearl Nitrile Examination Glove
Indications for Use (Describe)
Black Pearl Nitrile Examination Glove 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) SUMMARY
K232319
| 1.0 Submitter: | |
|---|---|
| Name | : UG Global Resources Sdn Bhd |
| Address | : Lot 62 & 63 Lorong Senawang 3/2,Kawasan Perindustrian Senawang,70450 Seremban, Negeri Sembilan,Malaysia. |
| Phone No. | : 606-676 0450 |
| Fax No. | : 606-679 5694 |
| Contact Person | : Ms. Lee Mei Ling |
| : meiling.lee@unigloves.com.my | |
| Date of Preparation | : 19th April 2024 |
2.0 Name of the Device
| Trade Name | : Black Pearl Nitrile Examination Glove |
|---|---|
| Common Name | : Non-Sterile, Powder Free, Nitrile Examination Gloves, Black |
| Classification Name | : Non-Powdered Patient Examination Glove (21 CFR 880.6250) |
| Class | : Class I |
| Product Code | : LZA |
3.0 Identification of the Predicate Devices that equivalency is claimed:
| Primary Predicate | : K112012, Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue |
|---|---|
| Company | : UG Healthcare (USA) Inc. |
| 510(k) | : K112012 |
| Classification Name | : Non-Powdered Patient Examination Glove (21 CFR 880.6250) |
| Class | : Class I |
| Product Code | : LZA |
4.0 Description of the Device:
Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
{5}------------------------------------------------
5.0 Intended Use of the Device
Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
6.0 Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
The Black Pearl Nitrile Examination Glove and predicate device are summarized with the following technological characteristics. Both gloves are made with nitrile and meets ASTM D6319-19 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
The device has similar technological characteristics with the predicate device in terms of product code, intended use, indications for use, device material, additive, direction for use, construction, sterility, acceptance criteria, physical properties, biocompatibility test, residual powder test and freedom from holes. The technological characteristics differences between both devices are colour and dimensions. However, both colour pigment are with same intended use (colourant for nitrile products) and both dimensions are within ASTM D6319-19 standard. The comparison analysis is presented in the table below:
| Characteristicandparameters | Non-Sterile, PowderFree, NitrileExamination GlovesBlueUG Healthcare (USA)Inc. K112012(Predicate) | Black Pearl NitrileExamination Glove(K232319) | ComparisonAnalysis | |
|---|---|---|---|---|
| Product Code | LZA | LZA | Same | |
| Intended use | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenthe patient and theexaminer. | Black Pearl Nitrile is adisposable device,intended for medicalpurposes that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Same | |
| Indications forUse | Non-Sterile, PowderFree, Nitrile ExaminationGloves Blue is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Black Pearl Nitrile is adisposable device,intended for medicalpurposes that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Same | |
| Device Material | Nitrile | Nitrile | Same | |
| Colour | Blue | Black | Different | |
| (Colourant for nitrileproducts) | (Colourant for nitrileproducts) | |||
| Additives | No flavour additive | No flavour additive | Same | |
| Direction for Use | Single Use Only | Single Use Only | Same | |
| Construction | Ambidextrous | Ambidextrous | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| AcceptanceCriteria | ASTM D6319-10 | ASTM D6319-19 | Same | |
| Device Tolerance & Specifications: | ||||
| Dimensions | Meets ASTM D6319-10Thickness at Finger -min. 0.05mmThickness at Palm -min. 0.05mm | Meets ASTM D6319-19Thickness at Finger -min. 0.05mmThickness at Palm -min. 0.05mm | Different | |
| Overall Length -240mm minimum | Length -Size XS - min. 220mmSize S - min. 220mmSize M - min. 230mmSize L - min. 230mmSize XL - min. 230mm | |||
| Width -Size M - 95mm | Width -Size XS - 70±10mmSize S - 80±10mmSize M - 95±10mmSize L - 110±10mmSize XL - 120±10mm | |||
| PhysicalProperties | Meets ASTM D6319-10:Tensile Strength: | Meets ASTM D6319-19:Tensile Strength: | Same | |
| BeforeAging | BeforeAging | |||
| AfterAging | AfterAging | |||
| Min. 14MPa | Min. 14MPa | |||
| Ultimate Elongation: | Ultimate Elongation: | |||
| BeforeAging | BeforeAging | |||
| AfterAging | AfterAging | |||
| min.500% | min.500% | |||
| min.400% | min.400% | |||
| BiocompatibilityTest | ||||
| a. SkinSensitizationTests | Non-sensitizer under theconditions of the study. | Non-sensitizer under theconditions of the study. | Same | |
| b. Irritation Tests | Non-irritant under the conditions of the study. | Non-irritant under the conditions of the study. | Same | |
| c. Cytotoxicity Test | Nil | Cytotoxic in undiluted (100%), 1:2 (50%), 1:4 (25%) and 1:8 dilution (12.5%). Non-cytotoxic to L-929 cells in 1:16 (6.25%) and 1:32 dilution (3.125%) | No test reports were submitted for predicate device | |
| d. Acute Systemic Toxicity | Nil | Did not induce any acute systemic toxicity in swiss albino mice under the conditions of the study. | No test reports were submitted for predicate device | |
| Residual Powder Test | Meets ASTM D6124-06: ≤ 2 mg/ glove | Meets ASTM D6124-06: ≤ 2 mg/ glove | Same | |
| Freedom from Holes | Meets ASTM D6319-10 Standard requirements | Meets ASTM D6319-19 Standard requirements | Same |
{6}------------------------------------------------
Traditional 510(k) Premarket Notification
Trade name: Black Pearl Nitrile Examination Glove
Trade name: Black Pearl Nitrile Examination Glove
Common name: Non-Sterile, Powder Free, Nitrile Examination Gloves, Black
{7}------------------------------------------------
{8}------------------------------------------------
7.0 Summary of Non-Clinical Testing
The performance test data of non-clinical tests meets ASTM D6319-19 and ASTM D6124 -06 (Reapproved 2017) standards requirements.
| TestPerformed | Device Description/Sample Size | Test Method/ApplicableStandard | Purpose ofTesting | GlovesSize | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Test Title:Dimensions | Gloves sampled fromthe finished product andidentified asNon-Sterile,Powder Free,NitrileExaminationGloves, Black.The inspectionlevel is S-2and theacceptablequality level(AQL) is 4.0.The lot size forthis samplingis 35,001 to150,000.Therefore, 13pieces ofgloves fromeach size wereused for thetesting. | ASTM D6319-19 | To measurethe length,width, andthickness ofgloves | XS | Length | Min. 220mm | Min. 242mm | Pass | ||
| Width | 70mm ±10mm | 77mm to 80mm | Pass | |||||||
| Thickness | Palm - Min. 0.05mmFinger - Min. 0.05mm | Palm - Min. 0.06mmFinger - Min. 0.08mm | Pass | |||||||
| S | Length | Min. 220mm | Min. 244mm | Pass | ||||||
| Width | 80mm ±10mm | 83mm to 86mm | Pass | |||||||
| Thickness | Palm - Min. 0.05mmFinger - Min. 0.05mm | Palm - Min. 0.06mmFinger - Min. 0.08mm | Pass | |||||||
| M | Length | Min. 230mm | Min. 241mm | Pass | ||||||
| Width | 95mm ±10mm | 96mm to 98mm | Pass | |||||||
| Thickness | Palm - Min. 0.05mmFinger - Min. 0.05mm | Palm - Min. 0.06mmFinger - Min. 0.08mm | Pass | |||||||
| L | Length | Min. 230mm | Min. 240mm | Pass | ||||||
| Width | 110mm ±10mm | 107mm to 110mm | Pass | |||||||
| Thickness | Palm - Min. 0.05mmFinger - Min. 0.05mm | Palm - Min. 0.06mmFinger - Min. 0.09mm | Pass | |||||||
| XL | Length | Min. 230mm | Min. 241mm | Pass | ||||||
| Width | 120mm ±10mm | 119mm to 124mm | Pass | |||||||
| Thickness | Palm - Min. 0.05mmFinger - Min. 0.05mm | Palm - Min. 0.06mmFinger - Min. 0.09mm | Pass | |||||||
| TestPerformed | Device Description/Sample Size | Test Method/ApplicableStandard | Purpose ofTesting | Acceptance Criteria | Results | Status | ||||
| Test Title:FreedomFromHoles | Gloves sampled from thefinished product andidentified as Non-Sterile,Powder Free, NitrileExamination Gloves,Black.The inspection level is G-1 and the acceptablequality level (AQL) is 2.5.The lot size for thissampling is 35,001 to150,000. Therefore, 200pieces of M-size gloveswere used for the testing. | ASTM D6319-19 | To detect holesthat leak waterand therebycompromise theusefulness of thegloves. | Sample size: 200 pcsInspection level: G-IAQL: 2.5Accept: 10 piecesReject: 11 pieces | During the test, 2 pieces werefound with holes. | Pass | ||||
| Test Title:PhysicalProperties | Gloves sampled from thefinished product andidentified as Non-Sterile,Powder Free, NitrileExamination Gloves,Black. The inspectionlevel is S-2 and theacceptable quality level(AQL) is 4.0. The lot sizefor this sampling is 35,001to 150,000. Therefore, 13pieces of M-size gloveswere used for the testing. | ASTM D6319-19 | To evaluate thephysical propertycharacteristics ofgloves. | BeforeAgingTensileStrength:Min. 14MPaUltimateElongation:Min. 500% | AfterAcceleratedAgingTensileStrength:Min. 14MPaUltimateElongation:Min. 400% | Before AgingTensileStrength:Min. 18.2MPaUltimateElongation:Min. 500% | AfterAcceleratedAgingTensileStrength: Min.17.4 MPaUltimateElongation:Min. 400% | Pass |
{9}------------------------------------------------
| TestPerformed | Device Description/Sample Size | TestMethod/ApplicableStandard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|---|
| Test Title:Powder-freeResidue | 5 pieces of gloves weresampled from the finishedproduct and identified asNon-Sterile, Powder Free,Nitrile Examination Gloves,Black. | ASTM D6124-06(Reapproved 2017) | To determinethe amount ofresidualpowder andnon-powdersolids foundon gloves. | ≤ 2.0mg/ glove | 0.70mg/ glove | Pass |
| Test Performed | Purpose of Testing | Device Description | Test Method | Results | Conclusion |
|---|---|---|---|---|---|
| Test title: SkinIrritation Test inNew ZealandWhite Rabbits | To determine theskin irritationpotential of the Non-Sterile, PowderFree, NitrileExamination Gloves,Black in NewZealand Whiterabbits. | Non-Sterile, PowderFree, NitrileExamination Gloves.Black is a non-sterileglove, intended formedical purpose thatis worn on theexaminers hand topreventcontaminationbetween patient andexaminer. It is asurface device whichcomes in contactwith skin. Theduration of contact isless than or equal to24 hours. | The test item that was cut and usedfor extraction was extracted usingphysiological saline (polar solvent)and cottonseed oil (non-polar solvent)at 37 ± 1 °C for 72 h and 20 minunder sterile conditions. Solventcontrols were also subjected to thesimilar extraction conditions.The test item extracts (0.5 mL) wasloaded on the absorbent gauze andplaced topically on the fur clippedarea of six rabbits (3 animals each forpolar and non-polar extracts). Thepatches were loosely held in contactwith the skin by semi-occlusivedressing with means of non-irritantadhesive tape for 24 h. The test siteswere marked with non-irritantpermanent ink.Animals were observed for threeconsecutive days for morbidity.mortality, skin reactions andabnormal clinical signs andsymptoms following the patchremoval. The skin reactions werevisually scored according to ISO10993-23:2021(E) at 24, 48 and 72 h. | No mortality or morbidity wasobserved in the experimentalanimals. A gradual increase inbody weight was observed in allthe animals at the end of theexperiment. No signs of clinicaltoxicity or overt toxicity wasobserved in any of the animals.Hence, gross pathology andhistopathology was notperformed. No local skinirritation was observed at thetest site in any of the animalsand the primary irritation indexobtained was '0'. | Based upon theresults obtained inthis study and inline with ISO10993-23:2021(E), thegiven test item.Non-Sterile.Powder Free,NitrileExaminationGloves, Black, isconsidered asnon-irritant underthe conditions ofthe present study. |
| Test Performed | Purpose of Testing | Device Description | Test Method | Results | Conclusion |
| Test title: SkinSensitization Testin Guinea Pigs | To determine theskin sensitizationpotential of the Non-Sterile, PowderFree, NitrileExamination Gloves,Black using guineapig maximization test(GPMT). | Non-Sterile, PowderFree, NitrileExamination GlovesBlack is a non-sterileglove, intended formedical purpose thatis worn on theexaminers hand topreventcontaminationbetween patient andexaminer. It is asurface device whichcomes in contactwith skin. Theduration of contact isless than or equal to24 hours. | The test item that was cut and usedfor extraction was extracted inphysiological saline (polar solvent)and cottonseed oil (non-polar solvent)at 37 ± 1 °C for 72 ± 2 h (Intradermalinduction - 72 h and 10 min, Topicalinduction - 72 h and 05 min,Challenge phase - 72 h and 10 min)under sterile conditions. Solventcontrols were subjected to similarextraction conditions.Animals were divided into fourgroups; G1 - five guinea pigs for polarsolvent control, G2 - ten guinea pigsfor polar test item extract, G3 - fiveguinea pigs for non-polar solventcontrol and G4 - ten guinea pigs fornon-polar test item extract. The furover the treatment sites was clippedand shaved on the day of treatment,prior to dosing on all the animals.Induction of sensitization was a two-stage procedure with intradermalinjections on day 0 (with Freund'scomplete adjuvant (FCA), solventcontrols and extracts), followed by atopical patch exposure on day 7 for48 h.On day 21, challenge patches wereapplied for 24 h. Skin reactiongrading was performed usingMagnusson and Kligman scale at 24hand 48 h, after removing thechallenge patches according to ISO10993-10:2010(E). | No mortality or morbidity wereobserved in any of the animalsused in this study. A gradualincrease in body weight wasobserved in all the animals atthe end of the experiment. Noskin sensitization reactions wereobserved in both control and testsites of all the animals.Therefore, no gross andhistopathological examinationwere conducted. | Based upon theresults obtained inthis study and inline with ISO10993-10:2010(E), thegiven test item,Non-Sterile,Powder Free,NitrileExaminationGloves, Black, isconsidered asnon-sensitizer toGuinea Pigsunder theconditions of thepresent study. |
{10}------------------------------------------------
| Test Performed | Purpose of Testing | Device Description | Test Method | Results | Conclusion |
|---|---|---|---|---|---|
| Test title: Test forin vitroCytotoxicity | To evaluate the invitro cytotoxicpotential of the testitem in L-929 mousefibroblasts cellsusing elution method | Non-Sterile, PowderFree, NitrileExamination Gloves,Black is a non-sterileglove, intended formedical purpose thatis worn on theexaminers hand topreventcontaminationbetween patient andexaminer. Accordingto ISO 10993-1:2018,this is classified as asurface devicecontacting skin, for≤ 24 hours (limitedexposure) | The test item (both inner and outersurfaces) was cut and extracted at aratio of 6 cm2 per mL in extractionmedium at 37 ± 1 °C for 24 ± 2 h.Test item was extracted in 12 mL ofextraction medium at 37 ± 1 °C for 24h and 15 minutes under asepticcondition. Negative control (bothsides) was extracted in 7 mL ofextraction medium at 37 ± 1 °C for 24h and 15 minutes. Positive control(both sides) was extracted in 7 mL ofextraction medium at 37 ± 1 °C for 24h and 15 minutes. Vehicle control(MEM 05) was also subjected to thesame extraction condition.Exponentially growing L-929 mousefibroblasts cells were seeded in 96-well plate at 1 x 104 cells per well.After 24 h, 1x MEM supplementedwith 10% heat inactivated foetalbovine serum and 1%penicillin/streptomycin solution(complete growth medium) wasremoved and replaced with a seriesof six different dilution of the test itemextract ((Undiluted (100%), 1:2dilution (50%), 1:4 dilution (25%), 1:8dilution (12.5%), 1:16 dilution (6.25%)and 1:32 dilution (3.125%)), mediumblank, vehicle, positive and negativecontrol extract. The cell cultureswere then incubated at 37 ± 1°C for24 h with 5% CO2. After incubation,the cells were subjected to qualitativemeasurements viz., cytotoxicity wasgraded based on the morphology ofthe cells. | The cultures treated with the testitem extract at undiluted (neatextract) (100%), 1:2dilution (50%), 1:4 dilution(25%), 1:8 dilution (12.5%)showed complete destructionof the cell layers (grade 4).However, at dilutions 1:16dilution (6.25%) and 1:32dilution (3.125%) did not showany cytotoxic response (grade0). | Based upon theresults obtained inthis study and inline with ISO10993-5:2009, itis concluded thatthe given testitem, Non-Sterile,Powder Free,NitrileExaminationGloves, Black isconsidered ascytotoxic inundiluted (neatextract) (100%),1:2 dilution (50%)1:4 dilution (25%)and1:8 dilution(12.5%). Non-cytotoxic to L-929cells in 1:16dilution (6.25%)and 1:32dilution (3.125%). |
| Test Performed | Purpose of Testing | Device Description | Test Method | Results | Conclusion |
| Test title: AcuteSystemic ToxicityTest in SwissAlbino Mice | To determine theacute systemictoxicity potential ofthe test item inSwiss albino mice. | Non-Sterile, PowderFree, NitrileExamination Gloves,Black is a non-sterileglove, intended formedical purpose that | The test item that was cut and usedfor extraction was extracted at a ratioof 6 cm2/mL of polar solvent(physiological saline) as well as non-polar solvent (cottonseed oil) at 37 ±1 °C for 72 h and 18 minutes. Solvent | No mortality or morbidity wasobserved in test item extractsadministered animals. A gradualincrease in body weight wasobserved in all the animals atthe end of experiment. No clinical | Based upon theresults obtainedand in line withISO 10993-11:2017(E), it isconcluded that |
| Systemic ToxicityTest in SwissAlbino Mice | acute systemictoxicity potential ofthe test item inSwiss albino mice. | Free, NitrileExamination Gloves,Black is a non-sterileglove, intended formedical purpose thatis worn on theexaminers hand topreventcontaminationbetween patient andexaminer. Accordingto ISO 10993-1:2018(E), this is asurface device whichcomes in contactwith skin for ≤ 24hours (limitedexposure). | for extraction was extracted at a ratioof 6 cm2/mL of polar solvent(physiological saline) as well as non-polar solvent (cottonseed oil) at 37 ±1 °C for 72 h and 10 minutes. Solventcontrols were also subjected to thesame temperature and timeconditions.Four groups of mice, each comprisingof five males were used for this study.Two groups (G1 and G2) weretreated intravenously with polarsolvent control and polar extract,respectively at a dose volume of 50mL/kg body weight in two divideddoses at an interval of 1 h and 35minutes within a 24 h period. Anothertwo groups (G3 and G4) were treatedintraperitoneally with non-polarsolvent control and non-polar extractrespectively at a dose volume of 50mL/kg body weight in a single dose.The animals were observed for threeconsecutive days for morbidity,mortality, body weight and for anyabnormal clinical signs and | observed in test item extractsadministered animals. A gradualincrease in body weight wasobserved in all the animals atthe end of experiment. No signsof clinical toxicity or overt toxicitywas observed in any of theanimals; hence, gross pathologyand histopathology was notperformed. | results obtainedand in line withISO 10993-11:2017(E), it isconcluded thatthe given testitem, Non-Sterile,Powder Free,NitrileExaminationGloves, Black didnot induce anysystemic toxicityin swiss albinomice under theconditions of thepresent study. |
|---|---|---|---|---|---|
| --------------------------------------------------- | ----------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{11}------------------------------------------------
8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.