(121 days)
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text describes the acceptance criteria and performance data for the "Penta Glove," a Blue Nitrile Examination Glove. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a de novo approval process.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|
| ASTM D6319-2019 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 246 mm, Small: 246 mm, Medium: 248 mm, Large: 248 mm, X-Large: 250 mm | Meets criteria |
| ASTM D6319-2019 (Width) | To determine the width of the gloves | X-small: 70±10 mm, Small: 80±10 mm, Medium: 95±10 mm, Large: 110±10 mm, X-Large: 120±10 mm | X-small: 68 mm, Small: 80 mm, Medium: 92 mm, Large: 105 mm, X-Large: 115 mm | Meets criteria (all reported values are within the +/-10mm range of the nominal size criteria) |
| ASTM D6319-2019 (Thickness) | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | X-Small: 0.12mm (Palm), 0.20mm (Finger); Small: 0.12mm (Palm), 0.20mm (Finger); Medium: 0.12mm (Palm), 0.20mm (Finger); Large: 0.12mm (Palm), 0.20mm (Finger); X-Large: 0.12mm (Palm), 0.20mm (Finger) | Meets criteria |
| ASTM D6319-2019 (Physical Properties - Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: 14 Mpa Min for all sizes; After Ageing: 14 Mpa Min for all sizes | Before Ageing: X-Small 18.45 Mpa, Small 18.54 Mpa, Medium 18.62 Mpa, Large 18.67 Mpa, X-Large 18.72 Mpa; After Ageing: X-Small 17.54 Mpa, Small 17.56 Mpa, Medium 17.68 Mpa, Large 17.75 Mpa, X-Large 17.80 Mpa | Meets criteria (all reported values are above 14 Mpa) |
| ASTM D6319-2019 (Physical Properties - Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: 500% Min for all sizes; After Ageing: 400% Min for all sizes | Before Ageing: X-Small 686%, Small 690%, Medium 694%, Large 702%, X-Large 705%; After Ageing: X-Small 659%, Small 665%, Medium 668%, Large 670%, X-Large 674% | Meets criteria (all reported values are above the minimums) |
| ASTM D5151-2019 (Water Tight / Holes) | To determine the holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | Meets criteria |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder) | To determine the residual powder in the gloves | 2 Mg/Glove Max | X-small: 0.21mg/glove, Small: 0.21mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove | Meets criteria |
| ISO 10993-10 (Primary Skin Irritation) | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant | Meets criteria |
| ISO 10993-10 (Dermal Sensitization) | To determine the skin sensitization potential of the material in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Meets criteria |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. | Does Not Meet Criteria (Reported as "cytotoxic" against a "non cytotoxic" acceptance criteria, though in the previous F. Summary of Technological Characteristics, it was listed as "Same" as predicate with predicate also being "cytotoxic"). This discrepancy needs clarification. |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Meets criteria |
| USP 42 <85> (Bacterial Endotoxin) | To determine the Bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves | <20 EU/pair of gloves | Meets criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each individual test. However, it references ASTM and ISO standards for the testing. These standards typically outline the required sample sizes for performing such tests (e.g., number of gloves per batch for AQL, number of animals for biocompatibility).
- Data Provenance: The testing appears to be conducted by the manufacturer or a contracted lab to meet international standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series, USP 42). The submitter, Pentavest Holdings Sdn Bhd, is located in Malaysia. Thus, the data provenance is likely from Malaysia or other regions where these standard tests are performed. The data is prospective for the device being submitted, as these tests would have been performed on samples of the Penta Glove specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes the testing of a medical device (examination gloves) based on objective, standardized measurements and laboratory tests (e.g., tensile strength, dimensions, chemical residue, cytotoxicity, etc.). These tests rely on equipment and technical procedures to generate quantifiable results, not expert consensus or interpretation of subjective images/data. Therefore, there's no "ground truth" established by experts in the typical sense of clinical or diagnostic studies.
4. Adjudication Method for the Test Set:
This is not applicable. As mentioned above, the tests are objective measurements and laboratory analyses, not human interpretation requiring adjudication. Results are compared against predefined numerical or qualitative acceptance criteria specified in the relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This is not applicable. The device is an examination glove, a physical medical device. It is not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable for the same reason as point 5. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on objective, quantitative measurements and established international standards (ASTM, ISO, USP). For example:
- Dimensions: Measured values compared to specified minimums/ranges.
- Physical Properties: Measured tensile strength and elongation compared to minimum requirements.
- Water Tightness: Tested against an Acceptable Quality Level (AQL) specification (e.g., 1.5).
- Residual Powder: Measured mass of powder per glove compared to a maximum limit.
- Biocompatibility: In-vitro or in-vivo biological responses (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, endotoxin levels) are observed and compared against predefined criteria for biological safety (e.g., "not an irritant," "not a sensitizer," "non cytotoxic," "do not pose a systemic toxicity concern," "NMT 20 EU/pair").
8. The Sample Size for the Training Set:
This is not applicable. The Penta Glove is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
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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.
January 6, 2022
Pentavest Holdings Sdn Bhd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K212847
Trade/Device Name: Penta Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 1, 2021 Received: September 7, 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212847
Device Name
Penta Glove
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | ☐ Residential Use (Part 1 CFR 201, Subpart D)☑ Day-Care Use (Part 1 CFR 201, Subpart G) | ☐ Residential Use (Part 1 CFR 201, Subpart D) | ☑ Day-Care Use (Part 1 CFR 201, Subpart G) |
|---|---|---|---|
| ☐ Residential Use (Part 1 CFR 201, Subpart D) | ☑ Day-Care Use (Part 1 CFR 201, Subpart G) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY As required by: 21CFR§807.92(c)
| 510(K) Owner's Name | Pentavest Holdings Sdn Bhd |
|---|---|
| Address | No. 9574-9578, Jalan PTB 2 ,Kawasan Perindustrian Tangga,Batu , 76400 Melaka, Malaysia |
| Phone | +601 22332689 |
| Fax | --- |
| bjteng@pentavest.com.my | |
| Contact Person | Teng Boon Joo |
| Designation | Managing Director |
| Contact Number | +601 22332689 |
| Contact Email | bjteng@pentavest.com.my |
| Date Submitted | 01 September 2021 |
A. APPLICANT INFORMATION
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | PENTA GLOVE |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | ---- | ||
| Name of device | JR MEDIC Blue NitrileExamination GlovesPowder-free | Blue NitrileExamination GlovesPowder Free | ---- | |
| Dimensions | ASTMD 6319-2019 | Length Min 230 m WidthMin 95+/-10mm(for medium size) | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Same |
| Physical Properties | ASTMD 6319-2019 | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strength min14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Same |
| Thickness | ASTMD 6319-2019 | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Residue | ASTMD 6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy not an irritant | Under the conditionof study not anirritant | Same |
| DermalSensitization- ISO10993-10:2010(E) | Under the conditions ofthe study not a sensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditionsof the study, cytotoxic | Under the conditionsof the study,cytotoxic | Same | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionsof study the deviceextracts do not pose asystemic toxicity concern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Same | |
| Bacterial Endotoxintest USP 42<85> | No data available | <20EU/pair of gloves | ---- | |
| Characteristics | Standards | Device Performance | Remarks | |
| Predicate | Current | |||
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | JR MEDIC Blue NitrileExamination GlovesPowder-free isdisposable devicesintended for medicalpurpose that are won onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Blue NitrileExamination GlovesPowder free is adisposable deviceintended for medicalpurpose that are wonon the examiner'shand to preventcontaminationbetween patient andexaminer. | Similar | |
| Material | ASTMD 6319-2019 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger Texture | Same |
| Size | ASTMD6319-2019 | Extra Small, Small,Medium, Large, ExtraLarge | Extra Small, Small,Medium, Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | Pentavest Holdings SdnBhd | ------ |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319.
NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thelength of the gloves | Min 230 mm for all sizes | X-Small:- 246 mmSmall:- 246 mmMedium:- 248 mmLarge:- 248 mmX-Large:- 250 mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | X-small:- $70\pm 10$ mmSmall:- $80\pm 10$ mmMedium:- $95\pm 10$ mmLarge:- $110\pm 10$ mmX-Large:- $120\pm 10$ mm | X-small- 68 mmSmall:- 80 mmMedium:- 92 mmLarge:- 105 mmX-Large:- 115 mm |
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| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | SizeX-Small 0.12mm 0.20mmSmall 0.12mm 0.20mmMedium 0.12mm 0.20mmLarge 0.12mm 0.20mmX-Large 0.12mm 0.20mm |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties-Tensile strength | Before AgeingTensile Strength 14Mpa Min for all sizesAfter AgeingTensile Strength 14Mpa Min for all sizes | SizeBefore ageingX-Small 18.45Mpa 17.54MpaSmall 18.54Mpa 17.56MpaMedium 18.62Mpa 17.68MpaLarge 18.67Mpa 17.75MpaX-Large 18.72Mpa 17.80Mpa |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties-Ultimate Elongation | Before AgeingUltimate Elongation 500% Min for all sizesAfter AgeingUltimate Elongation 400% Min for all sizes | SizeBefore ageingX-Small 686% 659%Small 690% 665%Medium 694% 668%Large 702% 670%X-Large 705% 674% |
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | SizeX-smallSmallMediumLargeX-LargeResidual PowderContent0.21mg/glove0.21mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Under theconditions of studynon cytotoxic | Under the conditions ofthe study cytotoxic. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| Bacterial Endotoxin testUSP 42<85> | To determine the BacterialEndotoxin limit in the glove | NMT 20 EU/pair ofgloves | <20 EU/pair of gloves |
G. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
H. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is as effective, and performs as well as than the legally marketed predicate device 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.