(47 days)
The powder-free 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.
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.
This document describes the acceptance criteria and study results for the AMADEX Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|---|
| Dimensions | ASTM D 6319-10 | ||||
| Length | To determine the length of the gloves | Min 230 mm (All Sizes) | >230 mm (Passes) | Same | |
| Width (XS) | 70 ± 10 mm | 76 ± 3 mm | Same | ||
| Width (S) | 80 ± 10 mm | 84 ± 3 mm | Same | ||
| Width (M) | 95 ± 10 mm | 94 ± 3 mm (Also reported as 98 ± 2 mm, which passes 95 ± 10 mm) | Same | ||
| Width (L) | 110 ± 10 mm | 105 ± 3 mm | Same | ||
| Width (XL) | 120 ± 10 mm | 113 ± 3 mm | Same | ||
| Physical Properties | ASTM D 6319-10 | To determine the physical properties (Tensile strength and Elongation) | |||
| Tensile Strength (Before Aging) | 14 Mpa min | 24.5 Mpa (Passes) (Also reported as 14 Mpa in comparison table) | Same | ||
| Ultimate Elongation (Before Aging) | 500% min | 500% (Implied, as result is 14 Mpa and 500% in comparison table) | Same | ||
| Tensile Strength (After Aging) | 14 Mpa min | 14 Mpa (Implied) | Same | ||
| Ultimate Elongation (After Aging) | 400% min | 400% (Implied) | Same | ||
| Thickness | ASTM D 6319-10 | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min | Palm: 0.09 mm (Passes), Finger: 0.12 mm (Passes) | Same |
| Powder Free | ASTM D 6319-10, D 6124-06 | To determine the amount of residual powder and non-powder solids found on gloves | < 2 mg / glove | 0.60 mg / glove (Passes) | Same |
| Water Tightness | ASTM D 5151-06 | To determine the holes in the gloves | AQL 2.5 | AQL 2.5 (Passes) | Same |
| Biocompatibility | ISO 10993-10 | To determine the potential irritation of the effect likely to arise from a single exposure of test material on the intact skin of rabbits. | Under the condition of study not an irritant | Under the condition of study not an irritant | Same |
| ISO 10993-10 | To evaluate the potential of a test material to cause a delayed hypersensitivity reaction (Type IV) following exposure of the skin of guinea pigs. | Under the condition of study not an irritant | Under the condition of study not an irritant | Same | |
| Rubber Examination Gloves (General) | ASTM D 3578-05 | To determine the specifications for rubber examination gloves | Dimension, AQL: 4.0; Length: min 230 mm; Force at Break, AQL: 4.0, Tensile and Modulus | Meet the requirements of ASTM 3578 until 5 years (Passes) | - |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. However, it states that "All testing meets requirements for Physical and Dimensions testing conducted on gloves" based on the listed ASTM and ISO standards. These standards typically define the sampling plans and statistical methods for demonstrating compliance.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer, Megine Industries Sdn Bhd, Malaysia, based on non-clinical testing performed to establish substantial equivalence for their device. The tests are described as non-clinical testing, implying the data is generated specifically for this submission. The nature of the tests (physical, chemical, and biocompatibility) suggests this is data collected under controlled laboratory conditions, likely prospective testing for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The product is an examination glove, and the "ground truth" is established through adherence to recognized international and national consensus standards (ASTM and ISO) for physical, chemical, and biocompatibility properties. These standards define objective performance criteria and test methods, rather than relying on expert clinical consensus or interpretation of complex medical data.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or image interpretation tasks where multiple human readers or experts evaluate data and consensus is needed. The testing for these gloves involves objective laboratory measurements against predefined acceptance criteria from established standards.
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
This section is not applicable. An MRMC study is relevant for AI-powered diagnostic devices or systems where human performance is being evaluated and compared with or without AI assistance. This device is a passive examination glove and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a physical medical device (examination glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements and predefined specifications within recognized international and national consensus standards. Specifically:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D3578-05, 2015 Standard Specification for Rubber Examination Gloves
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Test for irritation and Skin Sensitization
These standards define the acceptable range for physical dimensions, mechanical properties, chemical residue, and biocompatibility, which serves as the definitive set of performance requirements.
8. The sample size for the training set
This section is not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control systems in the production of the physical gloves.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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June 16, 2021
Megine Industries Sdn Bhd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K211310
Trade/Device Name: AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 11, 2021 Received: June 14, 2021
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Ortega, PhD Acting 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) K211310
Device Name
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange)
Indications for Use (Describe)
The powder-free 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.
| 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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MEGINE INDUSTRIES SDN BHD
510 (K) SUMMARY ----------
This summary of 510(K) is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR807.92.
Collicit conceller and en artifies
The assigned 510 (K) number is: K211310
I. APPLICANT INFORMATION:
| 510 (K) Owner's Name | MEGINE INDUSTRIES SDN BHD |
|---|---|
| Address | B-05-02, The Vertical Business Suites, 8, Jalan Kerinchi,Bangsar South, 59200 Kuala Lumpur, Malaysia |
| Phone | +60328566180 |
| Fax | +60328566180 |
| benjamin.ng@meginegroup.com.my | |
| Contact Person | Benjamin Ng Soong Jing |
| Designation | Managing Director |
| Contact Number | +60328566180 |
| Contact Email | benjamin.ng@rneginegroup.com.my |
| Date Submission | 28th April 2021 |
AT REAL ME
2. DEVICE IDENTIFICATION:
글
| Name of the Device | AMADEX-Nit1ile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) |
|---|---|
| Product Proprietary orTrade Name | AMADEX |
| Common or Usual Name | Examination Gloves |
| Classification Name | Patient Examination Glove |
| Device Classification | Class - I |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
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3. PREDICATE DEVICE INFORMATION:
| Predicate Device | Nitrite Examination Powder Free Glove, Black, NitrileExamination Powder Free Glove, Orange. |
|---|---|
| 510 (K) Number | K172867 |
| Regulatory Class | I |
| Product Code | LZA |
4. DEVICE DESCRIPTION:
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitril e - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is sing le-use device to prevent contamination between patient and examiner.
5. INDICATION OF USE:
The powder-free 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.
| Characteristics | Standards | Device Performance | Remark s | |
|---|---|---|---|---|
| Predicate | Subject | - | ||
| 5 10 (K) number | K172867 | (Kxxxxxx) | - | |
| Name of Device | NitrileExaminationPowder FreeGlove, Blac k,NitrileExaminationPowder FreeGlove, Orange. | AMADEX-Nitrile PowderFreeExaminationGloves Non-Sterile, (Blue,Black, Orange) | - | |
| Dimension s | ASTM D 6319-10Length:Range - Length: Min -240mm(All Size s ) | Res ult:Length h:Min 240mmBy Sizes: | Result:Length: Min240mmBy Sizes: | Sam e |
| Width:Range value -XS : Length : 220mm,Width: 70 ± 10 mmS : Length : 220mm,Width: 80 ± 10mmM : Length : 230mm,Width: 95 ± 10 mmL : Length : 230mm,Width: 110 ± 10mmXL : Length : 230mm,Width: 120 ± 10mm | XS-Width: 76 ± 3mmS -Width: 84 ± 3mmM-Width: 94 ± 3mmL -Width: 105 ± 3mmXL -Width: 113 ± 3mm | XS -Width: 76 ± 3mmS-Width: 84± 3mmM-Width: 94 ± 3mmL -Width: 105 ± 3mmXL -Width: 113 ± 3mm | ||
| PhysicalProperties | ASTM D 6319-10Tensile, Elongation -Before AgingRange:Tensile Strength min: > 14MpaUltimate Elongation Min:500%After AgingRange:Tensile Strength min: > 14MpaUltimate Elongation Min:400% | Before AgingResult: 14 Mpa500%After AgingResult: 14 Mpa,400% | Before AgingResult: 14 Mpa500%After AgingResult: 14 Mpa400% | Same |
| Thickness | ASTM D 6319-10Range:Thickness (mm)Single wall ( All Sizes )Finger:Typical Value: (0.10 -0.12)Palm:Typical Value: (0.07 -0.08) | Result:Finger: 0.10 ±0.02Palm: 0.07 ±0.02 | Result:Finger: 0.10 ±0.02Palm: 0.07 ±0.02 | Same |
| Powder Free | ASTM S 6319-10 | Result: | Result: | Same |
| Range:< 2 mg /glove | XS: 0.6 mg /gloveS: 0.8 mg /gloveM: 1.2 mg/gloveL: 0.6 mg /gloveXL: 1.0 mg /glove | XS: 0.6 mg /gloveS: 0.8 mg /gloveM: 1.2 mg/gloveL: 0.6 mg /gloveXL: 1.0 mg /glove | Same | |
| Biocompatibility | Primary SkinIrritation - ISO 10993-10:2010 (E) | Under thecondition onof study notan irritant | Under thecondition ofstudy notan irritant | Same |
| Dermal Sensitization Assay(Skin Maximization) - ISO10993-10:2010 (E) | Under thecondition ofstudy not anirritant | Under thecondition ofstudy not anirritant | Same |
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE: 6.
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MEG/NEINDUSTRIES SDN BHD
| Characteristics | Standards | Device Performance | Remark s | |
|---|---|---|---|---|
| Predicate | Subject | |||
| Intended use | - | A patientexaminationglove is adisposable gloveintended formedical purposethat is worn onthe examiner' shand or finger topreventcontaminationbetween patientand exam in er. | A powder-freepatientexamination gloveis a disposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner | - |
| Water Tight(1000 ml) | ASTM D 5151-06 | AQL 2.5PASSES | AQL 2.5PASSES | Same |
| Material | ASTM D 6910-10 | Nitrile | Nitrile | Same |
| Colour | - | Black,Orange | Black,Orange | Same |
| Blue | Different | |||
| Available Sizeswith colour | Black (XS, S, M,L, XL) | Black (XS, S, M,L, XL) | Same |
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| O range(XS,S,M,L,XL) | O range(XS,S,M,L,XL) | |||
|---|---|---|---|---|
| Blu e(XS,S,M,L,XL) | Different | |||
| Texture | - | Finger Texture | Finger Texture | Same |
| Sizes | ASTM D 6319-10 | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single Use | Medical Glove GuidanceManual - Labelling | Single Use | Single Use | Same |
| Manufacturer | GMP MedicareSdn Bhd,Malaysia | MegineIndustries SdnBhd, Malaysia | - |
-
- SUMMARY OF NON-CLINCIAL TESTING SUMMARY:
The standards used for Megine Industries Sdn Bhd glove production are Based on the listed standards. All testing meets requirements for Physical and Dimensions testing conducted on gloves.
- SUMMARY OF NON-CLINCIAL TESTING SUMMARY:
-
· ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
-
· ASTM D5151-19 Standard Test Method for Detection of Hole s in Medical Gloves
-
ASTM D6124 -06 Standard Test Method for Residual Powder on Medical Gloves
-
• ASTM D3578-05,2015 Standard Specification for Rubber Examination Gloves
-
ISO 10993-10: 2010, Biological evaluation of medical de vices Part 10: Test for irritation and Skin Sensitization
-
ISO 10993-10: 2010, Biologicalevaluation of medical devices Part 10: Test for irritation and Skin Sensitization
-
· ISO 1522 3-1:2016, Medical Devices Symbols to be used with medical device labels, labelling ad information to be supplied - Part I: General Requirements.
There are no special labeling claims and there is no claim as hypoallergic on the labels.
- a) Performance Data -
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ------------- | --------- | --------------------- | -------- |
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MEG/NE INDUSTRIES SON BHD
| MEG/NE INDUSTRIES SON BHD | |||
|---|---|---|---|
| ASTM D 6319- 10(Reapproved 2015)Standard specificationfor NitrileExamination Glovesfor MedicalApplication | To determine thelength of the gloves | Min 230 mm | >230 mm (Passes) |
| ASTM D 6319-10(Reapproved 2015)Standard specificationfor NitrileExamination Glovesfor MedicalApplication | To determine thewidth of the gloves | $95 \pm 10$ mm | $98 \pm 2$ mm (Passes) |
| ASTM D 6319-10(Reapproved 2015) | To determine thethickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min | Palm: 0.09 mm(Passes) |
| Standard specificationfor NitrileExamination Glovesfor MedicalApplication | Finger: 0.12 mm(Passes) | ||
|---|---|---|---|
| ASTM D 6319-10(Reapproved 2015)Standard specificationfor NitrileExamination Glovesfor MedicalApplication | To determine thephysical propertiesTensile strength | Before Ageing:Tensile strength14Mpa min | 24.5 Mpa (Passes) |
| ASTM D 5151-06(Reapproved 2015)Standard Test methodfor Detection of Holesin Medical Gloves | To determine the holesin the gloves | AQL 2.5 | AQL 2.5 (Passes) |
| ASTM D 6124-06(Standard Test Methodfor Residual Powder onmedical Gloves) | To determine theamount of residualpowder and non-powder solids foundon gloves | Less than 2 mg perglove | 0.60 mg / glove(Passes) |
| ASTM D 3578-05(Reapproved 2015)Standard Specificationfor RubberExamination Gloves | To determine thespecifications forrubber examinationgloves | Dimension, AQL: 4.0Length: min 230 mmForce at Break, AQL:4.0, Tensile andModul us | Meet the requirementsof ASTM 3578 until 5years (Passes) |
- b) Bio-Compatibility Data
| Test Method | Purpose | Acceptance Criteria | Re sult |
|---|---|---|---|
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MEG/NE INDUSTRIES SON BHD
| ISO 1099 3-10Biological Evaluationof Medic al DeviceTest for Irritation andSkin Sensitization.Test done forIrritation. | To deter mine thepotential irritation ofthe effect likely toarise from a singleexposure of testmaterial on the intactskin of rabbits. | Under the condition ofstudy not an irritant | Under the condition ofstudy not an irritant |
|---|---|---|---|
| ISO 10993-10Biological Evaluationof Medical De viceTest for Irritation andSkin Sensitization.Test done forsensitization. | To evaluate thepotential of a testmaterial to cause adelayedhypersensitivityreaction (Type IV)following exposure ofthe skin of guinea pigs. | Under the condition ofstudy not an irritant | Under the condition ofstudy not an irritant |
-
- Discussion of Clinical tests performed: Not Applicable - Clinical Data is not needed for Gloves or for most devices cleared by the 510 (K) process.
-
- Conclusion:
The conclusion drawn from the nonclinical test demonstrate that the subject device in 510 (K) submission Kl 72867. AMADEX Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, and Orange) 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.