(123 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.
The subject device in this 510(k) Notification is a Blue Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.
The provided text describes the acceptance criteria and the study conducted for the Brightway Nitrile Examination Glove, powder-free (blue).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally based on the ASTM D6319-10 standard for Nitrile Examination Gloves. The device performance is reported as meeting these specifications.
| Characteristic | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| Dimension Measurement | ASTM D6319-10 (Specific ranges for weight, length, width, thickness by size) | All samples passed all dimension measurements. No non-conformance reported. |
| Water-tightness (Freedom from Pinholes) | ASTM D5151-06; G2 AQL 1.0, Ac=5 Rej=6 | 1 total defective found across all sizes (in one sample's palm). Acceptance number is 5. Status: Pass. |
| Tensile Strength (Before Aging) | ASTM D6319-10: 14 MPa (Min) | Average Result: 24.351 MPa. Status: Pass. |
| Ultimate Elongation (Before Aging) | ASTM D6319-10: 500% (Min) | Average Result: 550.6%. Status: Pass. |
| Tensile Strength (After Aging) | ASTM D6319-10: 14 MPa (Min) | Average Result: 22.134 MPa. Status: Pass. |
| Ultimate Elongation (After Aging) | ASTM D6319-10: 400% (Min) | Average Result: 484.5%. Status: Pass. |
| Labeling | No special labeling claims or claims of gloves as hypoallergenic. | No special labeling claims or claims of gloves as hypoallergenic. |
| Device Materials | Nitrile Compound | Nitrile Compound |
| Indications for Use | Intended for medical purpose, to be worn on examiners hand or finger to prevent contamination between patient and examiner. | Intended for medical purpose, to be worn on examiners hand or finger to prevent contamination between patient and examiner. |
| Color | Blue | Blue |
| Length | ASTM D6319-10: > 230 mm | > 230 mm (230-258mm) |
| Width | ASTM D6319-10: 70±10 mm to 120±10 mm (sizes XS to XL) | 70±10 mm to 120±10 mm (sizes XS to XL) |
| Thickness | ASTM D6319-10: > 0.05 mm (palm & finger) | > 0.05 mm (Palm: 0.08mm-0.16mm; Finger: 0.12mm-0.19mm) |
| Residual Powder | ASTM D6319-10, ASTM D6124: Less than 2 mg per glove | Less than 2 mg per glove. Status: Pass. |
| Primary Skin Irritation test | ISO 10993-10: Not an irritant | Under conditions of the study, not an irritant. |
| Dermal Sensitization Assay | ISO 10993-10: Not a sensitizer | Under conditions of the study, not a sensitizer. |
| Systemic Toxicity | ISO 10993-10: No systemic toxicity revealed | Under conditions of study, did not reveal any systemic toxicity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2. Data provided is for Batch No: 6H10 03.
- Water-tight Test (Freedom from Holes): 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6.
- Physical Properties (Tensile Strength, Ultimate Elongation): 20 samples (1 sample for each size XS, S, M, L, XL x 4 replicates per size, but the table shows 20 distinct samples with sizes varying, suggesting 4 per size covering XS-XL). Sampling Plan: Single Normal S2 AQL: 2.5 Acc/Rej: 1/2.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Specific sample sizes are not explicitly stated for these tests within the provided document, but the tests were performed "under the conditions of the studies."
- Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd, which is based in Malaysia. The testing certificates are dated August 22, 2016, and the overall submission is dated March 24, 2017. This indicates the studies were conducted prior to the submission, likely as part of the device development and verification, making them retrospective in the context of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a patient examination glove. The "ground truth" for its performance is established by adherence to recognized industry standards (like ASTM D6319-10, ASTM D5151-06, ISO 10993-10). These standards define objective, measurable physical, chemical, and biological properties. Therefore, no human experts (like radiologists) are typically involved in establishing a "ground truth" for the physical and biological characteristics of a glove. The "ground truth" is the quantitative measurement against the standard specification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the assessment relies on objective measurements against predefined standards (e.g., tensile strength, dimensions, water leak test), there is no adjudication method described or required by human experts. The results are quantitative and directly compared to the specified limits.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (examination glove), not an AI-powered diagnostic tool, and therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical examination glove, not an algorithm.
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 laboratory test results compared against established international and national standards for medical gloves. This includes:
- Physical properties (e.g., length, width, thickness, weight, tensile strength, ultimate elongation)
- Barrier integrity (e.g., freedom from pinholes via water leak test)
- Chemical properties (e.g., residual powder)
- Biocompatibility (e.g., primary skin irritation, dermal sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device is a physical medical device (examination glove), not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not use a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Brightway Holdings Sdn Bhd G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, 42100 MY
Re: K163267
Trade/Device Name: Brightway Nitrile Examination Glove, powder free (blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: November 7, 2016 Received: November 21, 2016
Dear G. Baskaran:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163267
Device Name BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE)
Indications for Use (Describe)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE) is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
K163267
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE]
-
- Submitter :
| Company Name : | BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| Street Address : | Lot 1559, Jalan Istimewa, |
| Batu Belah, 42100 Klang | |
| Selangor Darul Ehsan. | |
| Country : | Malaysia |
| Phone No. : | 603-3343 1007 & 603-3343 1094. |
| Fax No. : | 603-3341 4800 |
| E-mail Address : | brightway@brightway919.com |
| Contact Person : | Mr. G. Baskaran (Group Managing Director) |
| baskar@brightway919.com | |
| Mr. Felix Darrel (Group Marketing Manager) | |
| felix.marketing@brightway919.com |
- 18th March 2017 2. Preparation Date :
-
- Name of the Device :
Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE]
{4}------------------------------------------------
Device Classification Name: Polymer Patient Examination Glove
(21 CFR 88.6250)
Device common or usual name : NITRILE EXAMINATION GLOVE
FDA Device Class : Class 1
Product Code : LZA
4. Identification of the Device :
Class I patient Examination Nitrile gloves, Powder Free, LZA, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
Predicate Device:
Legally Marketed Devices to which Substantial Equivalence is claimed ; K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color
5. Device Description :
The subject device in this 510(k) Notification is a Blue Examination Glove.
The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).
The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.
This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath
The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012; Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves
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6. Intended use of the Device
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.
7. Specification For Nitrile gloves
7.1. Dimension and Thickness of Gloves
Certificate No : 6H22 06
Date : 22/08/2016
Brand : 9.5" Textured Non Sterile Blue Nitrile Exam Gloves.
Prd Description : Brightway Brand Textured Non Sterile Nitrile Examination Gloves, Powder Free (Blue)
Standard Specification for Nitrile Examination Gloves for Medical Application Test Method: ASTM D6319-10
Dimension Measurement
Test Method: ASTM D6319-10 Sample tested: 20 pieces per Batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2
Batch No: 6H10 03
| Sample No. | Size | Weight (g) | Length (mm) | Width (mm) | Thickness (mm) | ||
|---|---|---|---|---|---|---|---|
| 1 | XS | 4.5 | 240 | 75 | 0.16 | 0.13 | 0.085 |
| 2 | XS | 4.6 | 241 | 76 | 0.155 | 0.125 | 0.09 |
| 3 | XS | 4.6 | 241 | 76 | 0.16 | 0.13 | 0.085 |
| 4 | XS | 4.5 | 240 | 78 | 0.165 | 0.12 | 0.095 |
| 5 | S | 5.3 | 242 | 87 | 0.155 | 0.125 | 0.085 |
| 6 | S | 5.2 | 239 | 87 | 0.155 | 0.13 | 0.09 |
| 7 | S | 5.4 | 242 | 87 | 0.165 | 0.13 | 0.085 |
| 8 | S | 5.3 | 242 | 86 | 0.155 | 0.125 | 0.095 |
| 9 | M | 6.0 | 240 | 97 | 0.16 | 0.13 | 0.085 |
| 10 | M | 6.1 | 239 | 96 | 0.155 | 0.125 | 0.09 |
| 11 | M | 5.9 | 241 | 96 | 0.16 | 0.125 | 0.085 |
| 12 | M | 6.1 | 240 | 97 | 0.165 | 0.13 | 0.095 |
| 13 | L | 7.2 | 240 | 115 | 0.155 | 0.12 | 0.085 |
| 14 | L | 7.1 | 241 | 116 | 0.16 | 0.125 | 0.09 |
| 15 | L | 7.0 | 241 | 117 | 0.165 | 0.13 | 0.08 |
| 16 | L | 7.2 | 240 | 115 | 0.155 | 0.125 | 0.095 |
| 17 | XL | 7.3 | 240 | 122 | 0.165 | 0.125 | 0.085 |
| 18 | XL | 7.4 | 239 | 121 | 0.155 | 0.12 | 0.085 |
| 19 | XL | 7.2 | 242 | 120 | 0.16 | 0.13 | 0.09 |
| 20 | XL | 7.3 | 241 | 122 | 0.155 | 0.12 | 0.095 |
| Specification For XS4.6 ± 0.3g | Min - 230Tar - 242Max - 258 | Min - 60Tar - 70Max - 80 | Min - 0.12Tar - 0.15Max - 0.19 | Min - 0.08Tar - 0.12Max - 0.16 | Min - 0.06Tar - 0.09Max - 0.13 | ||
| Specification For Small5.2 ± 0.3g | Min - 230Tar - 242Max - 258 | Min - 70Tar - 80Max - 90. | Min - 0.12Tar - 0.15Max - 0.19 | Min - 0.08Tar - 0.12Max - 0.16 | Min - 0.06Tar - 0.09Max - 0.13 | ||
| Specification For Medium6.1 ± 0.3g | Min - 230Tar - 242Max - 258 | Min - 85Tar - 95Max - 105 | Min - 0.12Tar - 0.15Max - 0.19 | Min - 0.08Tar - 0.12Max - 0.16 | Min - 0.06Tar - 0.09Max - 0.13 | ||
| Specification For Large7.0 ± 0.3g | Min - 230Tar - 242Max - 258 | Min - 100Tar - 110Max - 120 | Min - 0.12Tar - 0.15Max - 0.19 | Min - 0.08Tar - 0.12Max - 0.16 | Min - 0.06Tar - 0.09Max - 0.13 | ||
| Specification For XL7.2 ± 0.3g | Min - 230Tar - 242Max - 258 | Min - 110Tar - 120Max - 130 | Min - 0.12Tar - 0.15Max - 0.19 | Min - 0.08Tar - 0.12Max - 0.16 | Min - 0.06Tar - 0.09Max - 0.13 | ||
| Number of non-conformance | 0 | 0 | 0 | 0 | 0 | ||
| Status | Pass | Pass | Pass | Pass | Pass |
3
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7.2. Gloves Physical Properties and Freedom From Holes
Water-tight Test
Test method: ASTM D5151- 06
Sample tested: 200 pieces per Batch.
Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6
| Location of holes | Size : X - Small | Size : Small | Size : Medium | Size : Large | Size : X - Large |
|---|---|---|---|---|---|
| Cuff | 0 | 0 | 0 | 0 | 0 |
| Palm | 0 | 1 | 0 | 0 | 0 |
| Finger-tip | 0 | 0 | 0 | 0 | 0 |
| Total defective Found | 1 | ||||
| Acceptance number | 5 | ||||
| Status | Pass |
BRIGHTWAY HOLDINGS SDN BHD Testing Services Physical Properties Analysis Report
| Certificate No | : | 6H22 168 | Date | : | 22/08/2016 |
|---|---|---|---|---|---|
| Customer | : | N/A | |||
| Brand | : | 9.5"Textured Non Sterile Blue Nitrile Exam Glove. | |||
| PO No | : | N/A | |||
| PI No | : | N/A | |||
| Batch No | : | 6H10 03 | |||
| Product Description | : | Brightway Brand Textured Non Sterile Nitrile Examination Glove, Powder Free [Blue] | |||
| Sample Receiving Date | : | 14.08.2016 | |||
| Sampling Plan | : | Single Normal S2 AQL: 2.5 Acc/Rej : 1/2 . | |||
| Sizes Comprising Of | : | XS, S, M, L & XL | |||
| Test Method | : | ASTM D 6319 - 10 | |||
| Test Conducted on | : | 21/08/2016 | |||
| Aging | : | 70 +/- 2 deg C for 168 Hrs . |
| Test EnvironmentCondition | Room Temperature (°C) : 23RH (%) : 48 | Room Temperature (°C) : 23RH (%) : 48 | ||||
|---|---|---|---|---|---|---|
| SampleNo | Size | Before Aging | After Aging | |||
| ModulusAt 500%( MPa ) | TensileStrength( MPa ) | UltimateElongation(%) | TensileStrength( MPa ) | UltimateElongation(%) | ||
| 1 | XS | 16.5 | 23.546 | 575.0 | 21.155 | 495.5 |
| 2 | XS | 18.2 | 24.852 | 546.2 | 22.459 | 481.2 |
| 3 | XS | 17.4 | 24.865 | 537.8 | 21.398 | 477.2 |
| 4 | XS | 19.3 | 23.654 | 562.3 | 23.546 | 499.3 |
| 5 | S | 16.5 | 24.784 | 543.7 | 21.654 | 487.7 |
| 6 | S | 18.4 | 23.123 | 569.5 | 22.478 | 454.0 |
| 7 | S | 17.7 | 23.321 | 544.4 | 21.398 | 451.2 |
| 8 | S | 18.6 | 24.512 | 562.3 | 23.485 | 486.8 |
| 9 | M | 17.4 | 25.845 | 543.7 | 21.145 | 495.6 |
| 10 | M | 19.4 | 24.956 | 569.5 | 22.409 | 485.5 |
| 11 | M | 16.9 | 23.698 | 544.4 | 21.545 | 479.6 |
| 12 | M | 17.6 | 24.654 | 575.4 | 23.348 | 496.5 |
| 13 | L | 18.2 | 25.415 | 568.7 | 21.145 | 492.9 |
| 14 | L | 17.8 | 23.154 | 522.2 | 22.365 | 457.3 |
| 15 | L | 16.3 | 24.856 | 519.4 | 21.398 | 489.3 |
| 16 | L | 18.7 | 23.156 | 530.5 | 23.348 | 487.7 |
| 17 | XL | 18.5 | 25.852 | 517.0 | 21.145 | 496.9 |
| 18 | XL | 17.8 | 23.465 | 596.0 | 22.409 | 498.5 |
| 19 | XL | 16.9 | 25.865 | 543.1 | 21.478 | 488.5 |
| 20 | XL | 17.8 | 23.456 | 541.8 | 23.369 | 489.7 |
| Average Result | 17.8 | 24.351 | 550.6 | 22.134 | 484.5 | |
| Cust. Requirement | N/A | 14 (Min) | 500 (Min) | 14(Min) | 400 (Min) |
Gloves meet all the specification listed in ASTM D 6319-10
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8. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41. The glove meet standards requirement referenced in section 6.0 above.
Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and did not reveal any systemic toxicity
Summary of Technical Characteristics and Substantial Equivalence Comparison Table 9.
The predicate device in scope is as follows:
The subject device and predicate device use a similar Nitrile barrier film to achieve a device for the intended use. The properties between the subject device and the predicate device are compared in the following table:
| Device Performance | ||||
|---|---|---|---|---|
| PredicateDevice:K143477- NitrilePatientExaminationGloves,Powderfree,Blue Color | Subject Device :K161215 -BRIGHTWAYBRAND NITRILEEXAMINATIONGLOVES,POWDER FREE,[BLUE] | |||
| Characteristics | Standard | Result ofComparison | ||
| Labeling | N/A | There are nospecial labelingclaims and do notclaim gloves ashypoallergenic onlabels. | There are nospecial labelingclaims and do notclaim gloves ashypoallergenic onlabels. | Same |
| Device Materials | N/A | Nitrile Compound | Nitrile Compound | Same |
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| Device Description | The subject devicein this 510(k)Notification is aBlue ExaminationGlove.The subject deviceis a patientexamination glovemade from a Nitrilecompound, Blue incolour, powder freeand non sterile (asper 21 CFR880.6250, class I).The principleoperation of themedical device toprovide single usebarrier protection | The subject device isa patientexamination glovemade of syntheticnitrile latexcompound. It is non-sterile, powderfreeand is Blue in color.The device isambidextrous andcan be worn oneither the left orright hand. Thedevice meets ASTM06319-10: Standardspecification forNitrile ExaminationGloves for MedicalApplication. Thesubject device issubstantiallyequivalent to legallymarketed Nitrileexamination glovesidentified as Productcode LZA. The deviceis for over-thecounter single use. | for the wearer andthe device thatmeets all therequirementspecifications forBarrier Protection,tensile properties asdefined in ASTMD6319-10 ;Standardspecification forNitrile ExaminationGloves.This device ismanufactured infacilities compliantto ISO 9001:2008certified inManufacture of NonSterile Natural(Latex) andSynthetic Latex(Nitrile)Examination |
|---|---|---|---|
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Surgical andIndustrial Gloves &Nitrile SheathThe device ismanufactured tocomply with ISO13485:2003 / ENISO 13485:2012;Manufacture of NonSterile Natural(Latex) andSynthetic Latex(Nitrile)Examination &Sterile SurgicalGloves | ||||
|---|---|---|---|---|
| The Nitrile PatientExaminationgloves,Powderfree, Bluecolor, is adisposable deviceintended formedical purposesthat is worn on theexaminers' handpreventcontaminationbetween patientand examiner | BRIGHTWAYBRAND NITRILEEXAMINATIONGLOVES, POWDERFREE, [BLUE] is adisposable deviceintended formedical purpose,to be worn on theexaminers handor finger topreventcontaminationbetween patientand examiner. | Same | ||
| Indications for use | N/A | |||
| Color | N/A | Blue | Blue | Same |
| Device Tolerances and Specifications & Performance Data | ||||
| Tensile strength :before and afterageing | ASTM 6319-10 | > 14Mpa ; PASS | > 14Mpa ; PASS | Same |
| UltimateElongation : | ASTM 6319-10 | > 500 % ; PASS | > 500 % ; PASS | Same |
| Before and afterageing | ||||
| ASTM 6319-10(FDA 1000 mlwater leaktest) | ||||
| Freedom fromPinholes | Pass | Pass | Same | |
| Dimensions: | ||||
| Length | ASTM 6319-10 | > 230 mm(240-400mm) | >230 mm(230-258mm) | Same |
| Width | ASTM 6319-10 | 70±10 mm to120±10 mm (sizesXS to XL) | 70±10 mm to120±10 mm (sizesXS to XL) | Same |
| Thickness | ASTM 6319-10 | > 0.05 mm (palm& finger) | > 0.05 mm(Palm :0.08mm-0.16mmFinger : 0.12mm-0.19mm) | Same |
| Residual Powder : | ASTM 6319-10,ASTM D6124 | Less than 2 mg perglove ; PASS | Less than 2 mgper glove ; PASS | Same |
| Biocompatibility | ||||
| Primary SkinIrritation test | ISO 10993-10 | Under conditionsof the study, notan irritant | Under conditionsof the study, notan irritant | Same |
| Dermalsensitization assay | ISO 10993-10 | Under conditionsof the study, not asensitizer | Under conditionsof the study, nota sensitizer | Same |
| Under conditionsof study, did notreveal any | PredicatedDevice did notundertake thetesting. SubjectDevice metrequirementsunder ISO |
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10.0 Conclusion
Based on intended uses, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is substantially equivalent to the predicate device K143477- Nitrile Patient Examination Gloves, Powder Free, Blue Color
The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards for physical properties requirements, pinhole requirements, biocompatibility requirements which are as shown and discussed above.
Based on the complete list of non-clinical tests, the subject device herein mentioned, is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.