(217 days)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color additive is added). The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
The provided document is a 510(k) premarket notification for a medical device: "Sterile Latex Surgical Gloves Powder Free." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness. As such, the information you've requested regarding acceptance criteria and study details for an AI/ML-based device is not entirely applicable to this document.
However, I can extract the closest equivalent information from the given text, focusing on the performance criteria by which the device's substantial equivalence was established.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed comparison of the subject device (Nulife / Sterile Latex Surgical Gloves Powder Free) against the predicate device (JR Medic Latex Surgeon's Gloves Sterile Powder Free) and references relevant ASTM and ISO standards for acceptance criteria.
| Criteria | Specification as per Standard (Acceptance Criteria) | Reported Device Performance (Subject Device K210969) | Predicate Device Performance (K192328) |
|---|---|---|---|
| Length (various sizes) | Min 245mm (Size 5.5), Min 265mm (Sizes 6-9) | 483mm - 487mm | 300 mm |
| Width (various sizes) | 70+/-6mm to 114+/-6mm | 71mm - 116mm | 78mm - 116mm (for corresponding sizes) |
| Finger Thickness (All sizes) | Min 0.10mm | 0.32mm | 0.21mm |
| Palm Thickness (All sizes) | Min 0.10mm | 0.20mm | 0.18mm |
| Cuff Thickness (All sizes) | Min 0.10mm | 0.15mm | 0.11mm |
| Tensile Strength (Before aging, All sizes) | 24Mpa minimum | 28.32Mpa | 26.0Mpa |
| Tensile Strength (After aging, All sizes) | 18Mpa minimum | 23.21Mpa | 22.0Mpa |
| Ultimate Elongation (Before aging, All sizes) | 750% minimum | 869% | 860% |
| Ultimate Elongation (After aging, All sizes) | 560% minimum | 730% | 725% |
| Stress at 500% (Before aging, All sizes) | 5.5 MPa Max | 5.1Mpa | 2.7 Mpa |
| Pinhole AQL (Before aging, All sizes) | Max 1.5 | 1.0 | 1.0 |
| Pinhole AQL (After aging, All sizes) | Max 1.5 | 1.0 | 1.0 |
| Powder residue (for powder free glove) | < 2 mg/Glove | 0.38 mg/Glove | 0.34 mg/Glove |
| Protein Content | < 50 µg/ dm² | 49µg/ dm² | 43µg/ dm² |
| Skin Irritation & Skin Sensitization | Non-irritant and Non-Sensitizer (ISO 10993-10) | Non-irritant and Non-Sensitizer | Non-irritant and Non-Sensitizer |
| In vitro cytotoxicity | Cytotoxicity determination (ISO 10993-5) | Cytotoxic | Cytotoxic |
| Material Mediated pyrogenicity | Non-pyrogenic (ISO 10993-11, USP 41 <151>) | Non pyrogenic | Non pyrogenic |
| Acute Systemic Toxicity | No systemic toxicity concern (ISO 10993-11) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | No data available |
| Bacterial Endotoxin | <20EU/pair of gloves (USP <85>) | <20EU/pair of gloves | No data available |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each of the non-clinical tests. It refers to compliance with standards like ASTM D3577-09, which would typically define the sample sizes required for such tests.
The data provenance is from bench tests conducted to verify design specifications. The manufacturer "MRK Healthcare Pvt Ltd" is located in Gujarat, India, suggesting the testing was performed there or coordinated by them. The document does not specify if the testing involved retrospective or prospective data collection; these are standard material property tests where samples are tested according to defined protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the evaluation of surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted and standardized test methods (e.g., ASTM, ISO) which define objective, measurable physical, chemical, and biological properties. This does not involve expert consensus in the way an AI/ML diagnostic device's performance is often evaluated against expert-annotated ground truth.
4. Adjudication method for the test set
Not applicable. The tests performed are objective measurements per standard protocols, not subjective assessments requiring 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 is not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these surgical gloves is based on:
- Standard Specifications: Requirements defined by recognized standards (e.g., ASTM D3577-09 for physical properties, ASTM D5151-06 for pinholes, ASTM D6124-06 for powder residue, ASTM D5712-15 and ASTM D6499-18 for protein content).
- Biocompatibility Standards: Requirements from ISO 10993 series and USP tests for biological safety (e.g., irritation, sensitization, cytotoxicity, pyrogenicity, bacterial endotoxin).
8. The sample size for the training set
Not applicable. This is not an AI/ML medical device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. There is no training set in the context of an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 3, 2021
MRK Healthcare Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K210969
Trade / Device Name: Nulife / Sterile Latex Surgical Gloves Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: September 28, 2021 Received: October 8, 2021
Dear Manoj Zacharias:
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
{1}------------------------------------------------
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 Clarence Murray, 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210969
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Type of Use (Select one or both, as applicable)
| Residential Use: For 1-4 STR/MTA Subject Sites |
|---|
| Group Tier Exception: 1-4 STR/MTA Subject Sites |
__ 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."
{3}------------------------------------------------
510K SUMMARY K210969 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | MRK Healthcare Pvt Ltd |
|---|---|---|
| 2 | Date Submitted | 26 OCT 2021 |
| 3 | Activity | Manufacturer |
| 4 | Address | S.No.153/P&310,Panch, Pippal,Hansapur,Runi, Unjha-Patan Road, Patan-384265, Gujarat. India. |
| 5 | Phone | +91 2766 297206 / 297207 |
| 6 | Fax | ------- |
| 7 | regulatorymrk@gmail.com | |
| 8 | Contact Person | Anil R Dave |
| 9 | Designation | Regulatory Assurance Officer |
| 10 | Contact Number | +91 2766 297206 / 297207 |
| 11 | Contact Email | regulatorymrk@gmail.com |
B.US AGENT & CONTACT PERSON INFORMATION
| 12 | US agent &contact person name | Manoj Zacharias |
|---|---|---|
| 13 | Address | Liberty Management Group Ltd.75 Executive Dr. STE 114, Aurora, IL-60504, USA. |
| 14 | Phone | (630) 270-2921 |
| 15 | Fax | (815) 986-2632 |
| 16 | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 17 | Common Name | Surgical Gloves |
|---|---|---|
| 18 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| 19 | Product proprietary ortrade name | Nulife |
| 20 | Classification name | Surgeon's Gloves |
| 21 | Device Classification | 1 |
| 22 | Product Code | KGO |
| 23 | Regulation Number | 21 CFR 878.4460 |
| 24 | Review Panel | General Hospital and Plastic Surgery |
{4}------------------------------------------------
D.PREDICATE DEVICE INFORMATION
| Description | Name of device | 510kNumber | 510K Owner |
|---|---|---|---|
| Predicatedevice | JR Medic Latex Surgeon's GlovesSterile Powder Free with proteincontent labeling claim of 50 µg/dm² or less per glove ofextractable protein | K192328 | JR Engineering & MedicalTechnologies (M) SDN.BHD.Lot 8 &10, Jalan Zurah 3& Lot 1&3, Jalan Zurah3A/1, Pusat Perindustrian2, 44200 Rasa, HuluSelangor, Selangor DarulEhsan, Malaysia. |
E. DESCRIPTION OF THE DEVICE
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color additive is added).
The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
F. INTENDED USE/INDICATION FOR USE:
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be
worn by operating room personnel to protect a surgical wound from contamination.
{5}------------------------------------------------
G. NON-CLINICAL TEST STANDARDS
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (2015):- Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10-Tests for irritation and skin sensitization.
ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests
USP 41 <151>Pyrogen Test
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose
USP <85>Bacterial Endotoxin Test
{6}------------------------------------------------
H. SUMMARY OF NON-CLINICAL PERFORMANCE TESTS ACCORDING TO ASTM D3577-09, STANDARD SPECIFICATION FOR RUBBER SURGICAL GLOVES
| Sl.No | Criteria | Specification as perASTMD3577-09,StandardSpecification forRubber SurgicalGloves | Average value ofsubject device | Whether subjectdevice compliedwiththeASTMD3577 -09,StandardSpecification forRubber SurgicalGloves |
|---|---|---|---|---|
| 1 | Length | |||
| Size 5.5 | Min 245mm | 483mm | Yes | |
| Size 6 | Min 265mm | 485mm | Yes | |
| Size 6.5 | Min 265mm | 486mm | Yes | |
| Size 7 | Min 265mm | 486mm | Yes | |
| Size 7.5 | Min 265mm | 486mm | Yes | |
| Size 8 | Min 265mm | 487mm | Yes | |
| Size 8.5 | Min 265mm | 487mm | Yes | |
| Size 9 | Min 265mm | 487mm | Yes | |
| 2 | Width | |||
| Size 5.5 | 70+/-6mm | 71mm | Yes | |
| Size 6 | 76+/-6mm | 74mm | Yes | |
| Size 6.5 | 83+/-6mm | 88mm | Yes | |
| Size 7 | 89+/-6mm | 92mm | Yes | |
| Size 7.5 | 95+/-6mm | 98mm | Yes | |
| Size 8 | 102+/-6mm | 103mm | Yes | |
| Size 8.5 | 108+/-6mm | 110mm | Yes | |
| Size 9 | 114+/-6mm | 116mm | Yes | |
| 3 | FingerThickness | Min 0.10mm | 0.32mm | Yes |
| (All sizes) | ||||
| 4 | Palm Thickness | Min 0.10mm | 0.20mm | Yes |
| (All sizes) | ||||
| 5 | Cuff Thickness | Min 0.10mm | 0.15mm | Yes |
| (All sizes) | ||||
| SL.NO | CRITERIA | Specification as perASTMD3577-09StandardSpecification forRubber SurgicalGloves | Average Valueof SubjectDevice | Whether SubjectDevice Complied withthe ASTMD3577 -09StandardSpecification forRubber SurgicalGloves |
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 28.32Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 23.21Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 869% | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 730% | Yes | |
| 8 | Stress at 500%before ageing(All sizes) | 5.5 MPa Max | 5.1Mpa | Yes |
| 9 | Pinhole AQL | |||
| Before aging(All sizes) | Max 1.5 | 1.0 | Yes | |
| After aging@70°C for 7 days(All sizes) | Max 1.5 | 1.0 | Yes |
SIZES AVAILABLE: -5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
{7}------------------------------------------------
{8}------------------------------------------------
I. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE
PREDICATE AND SUBJECT DEVICES
a. General Characteristics Comparison
| Characteristic | Subject deviceK210969 | Predicate deviceK192328 | Remarks | |
|---|---|---|---|---|
| Product Code | KGO | KGO | Same | |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Class | 1 | 1 | Same | |
| Intended Use/Indications of Use | A Sterile Latex SurgicalGloves Powder Free is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | A latex surgeon's glove is adevice made of naturalrubber intended to be wornby operating roompersonnel to protect asurgical wound fromcontamination. | Similar | |
| Powdered or Powderfree | Powder free | Powder free | Same | |
| Classification as perASTMD3577-09,Standard Specificationfor Rubber SurgicalGloves | Type I - gloves compoundedprimarily from naturalrubber latex | Type I - glovescompounded primarilyfrom natural rubber latex | Same | |
| Sterilization | ETO or Radiation,SAL- 10-6 | Radiation,SAL- 10-6 | Similar | |
| Label and Labeling | Meet FDA's labelRequirements | Meet FDA's labelRequirements | Same | |
| Special label claim | Protein content labelingclaim of 50µg/dm² or less perglove of extractable proteinfor Latex Surgeon's GlovesPowder Free. | Protein content labelingclaim of 50µg/dm² or lessper glove of extractableprotein for Latex Surgeon'sGloves Powder Free. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Characteristics | Acceptance criteria of the standard | Remarks | ||
| Subject deviceK210969 | Predicate deviceK192328 | |||
| DimensionsLength:- Min265 mm | 486 mm | 300 mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| Size5.5(70+/-6mm)6.0(76+/-6mm)6.5(83+/-6mm)7.0(89+/-6mm)7.5(95+/-6mm)8.0(102+/6mm)8.5(108+/6mm)9.0 (114+/6mm) | 71mm74mm88mm92mm98mm103mm110mm116mm | -78mm85mm88mm97mm103mm110mm116mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| Cuff, Palm,Finger Tip Min0.10 mm | Cuff-0.15mmPalm-0.20mmFinger Tip-0.32mm | Cuff-0.11mmPalm-0.18mmFinger Tip-0.21mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| Tensile Strength24Mpa minimum | 28.32Mpa | 26.0Mpa | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| UltimateElongation750% minimum | 869% | 860% | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| Stress at 500%5.5 MPa Max | 5.1Mpa | 2.7 Mpa | ||
| Tensile Strength18Mpa minimum | 23.21Mpa | 22.0Mpa | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| UltimateElongation560% minimum | 730% | 725% | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for Rubber SurgicalGloves | |
| Characteristics | Acceptance criteria of the standard | Remarks | ||
| SubjectdeviceK210969 | Predicate deviceK192328 | |||
| Freedom fromHolesAQL 1.5 | AQL 1.0 | AQL 1.0 | SimilarMeets ASTM D3577 andASTM D5151-06,( Reapproved 2015), Standard TestMethod for Detection of Holes inMedical Gloves | |
| Powder residuefor powder freeglove Powdercontent < 2mg/Glove | 0.38 mg/Glove | 0.34 mg/Glove | SimilarMeets ASTM D3577 and ASTMD6124-06,( Reapproved 2017),Standard Test Method for ResidualPowder on Medical Gloves | |
| Protein Content< 50 µg/ dm² | 49µg/ dm² | 43µg/ dm² | SimilarMeets ASTM D3577, ASTM D5712-15, Standard Test Method for theAnalysis of Aqueous ExtractableProtein in Natural Rubber and ItsProducts Using the Modified LowryMethod and ASTM D6499-18,Standard Test Method for theImmunological Measurement ofAntigenic Protein in Natural Rubberand Its Products | |
| Characteristics | Acceptance criteria of the standard | Remarks | ||
| Biocompatibility | Subject deviceK210969 | Predicate deviceK192328 | ||
| Skin Irritation &Skin Sensitization | ISO 10993-10,Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization | Non- irritant andNon-Sensitizer | Non- irritant andNon-Sensitizer | Same |
| In vitrocytotoxicity | ISO 10993-5:2009(E),BiologicalEvaluation of MedicalDevices - Part 5-Tests forin vitro Cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material Mediatedpyrogenicity | ISO 10993-11:2017(E),Biological Evaluation ofMedical Devices - Part11, Tests for SystemicToxicity and USP 41<151>Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| AcuteSystemicToxicity | ISO 10993-11:2017(E),Biological Evaluation ofMedical Devices - Part11, Tests for SystemicToxicity | Under theconditionsof study thedevice extracts donot pose asystemic toxicityconcern | No data available | ---- |
| BacterialEndotoxin | USP<85> | <20EU/pair ofgloves | No data available | ---- |
{9}------------------------------------------------
b. Technological Characteristics Comparison
{10}------------------------------------------------
{11}------------------------------------------------
The performance test data of the non clinical tests are the same as mentioned immediately above.
J. Substantial equivalence based on clinical performance data.
Clinical data was not required for this submission.
K. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device Sterile Latex Surgical Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192328, JR MEDIC Latex Surgeon's Gloves Sterile Powder Free.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).