(154 days)
The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.
Here's the summary of the acceptance criteria and reported device performance:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance (Non-Sterile, Powder Free Nitrile Examination Gloves) |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 (GII AQL = 2.5) & FDA 1000ml Water Leak Test | Meets (0 holes found in sample size of 80 for all models, with accept criteria of 5 and reject criteria of 6) |
| Length (mm) for Size M | Min 230 | 240-253 (range across all models) |
| Palm Width (mm) for Size M | 95 ± 10 | 95-99 (range across all models) |
| Thickness (mm) Finger (single layer) | Min 0.05 | 0.08-0.16 (range across all models) |
| Thickness (mm) Palm (single layer) | Min 0.05 | 0.06-0.12 (range across all models) |
| Powder-free | ASTM D6319-10 | Meets |
| Moisture Content (%) | Max 2.0% | 0.8% - 1.2% (Average across all models) |
| Residual Powder (mg/glove) | Max 2.0mg/glove (ASTM-D6124-10) | 0.10mg/l - 0.20mg/glove (range across all models; presented as a percentage in one instance for residual powder and mg/glove for moisture content) |
| Biocompatibility | Primary skin irritation: ISO 10993-10 (Non-Irritant)Dermal Sensitization: ISO 10993-10 (Non-sensitizer) | Non-IrritantNon-sensitizer (for all models) |
Study Proving Device Meets Acceptance Criteria:
The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).
-
Standards Used: The performance of the devices was evaluated against the following standards:
- ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
- FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
- ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
- ASTM-D6124-10 (Reapproved 2011) for Residual Powder.
-
Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.
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 information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.
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 information is not applicable as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML device.
{0}------------------------------------------------
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them that resemble hair or a wave-like design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
YTY Industry (MANJUNG) SDN. BHD. Mr. Andrew Lowery Official Correspondent QA/GMP Consultant 14004 Manor Road, P O Box 445 Phoenix, Maryland 21131
Re: K142283
Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H), Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: December 13, 2014 Received: December 18, 2014
Dear Mr. Lowery:
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.
{1}------------------------------------------------
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 device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K142283
Device Name
Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color]
Indications for Use (Describe)
The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose 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)
മ്മ 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.
The purcent of the completed on mornation is estimate the line operations of the many of the time to review instructions, search existing data sources, gather and maintain the data needed and comblete 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}------------------------------------------------
510 (K) SUMMARY SHEETS
| 1.0 | 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,Lot 1422-1424, Batu 10 Lekir32020 Sitiawan, PerakMalaysia |
| Tel | 605-6908533 | |
| Fax | 605-6908501 | |
| Name of Contact Person | 1. Ms. Punitha Samy | |
| Date Summary Prepared | January 13, 2015 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile, Powder Free Nitrile Examination Gloves[(8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) BlueColor, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)BlueColor, 8604T Black Color and 8617F White Color] | |
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient Examination Gloves, Powder Free | |
| Device Classification: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital (80) | |
| Product Code: | LZA |
4.0 Identification of The Legally Marketed Devices
Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] as described in this 510k Notification is substantially equivalent to the current Class I patient examination gloves bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application. Predicate 510(K) number for this application is K052502.
{4}------------------------------------------------
5.0 Description of The Device
Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This device is for over-the counter use.
7.0 Summary of Performance Data:
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-sterile, Powder Free Nitrile Examination [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T Black Color and 8617F White Color] Gloves have the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristic | Standards | Performance ofNon-Sterile, Powder FreeNitrile Examination Gloves |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 | Meets |
| Powder-free | ASTM D6319-10 | Meets |
| Bio-compatibility | Primary skin irritationISO 10993-10Dermal SensitizationISO 10993-10 | Non-IrritantNon-sensitizer |
{5}------------------------------------------------
| Performance data of gloves based on ASTNI D6519-10 and FDA 1000ML water leak test. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Test | FDA | YTY Powder Free Nitrile Examination Gloves | |||||||
| 1000ml | |||||||||
| Water | |||||||||
| Leak Test | Blue 8603 | White | |||||||
| 1. Watertight | MultipleNormal | Blue8603F | Blue8611F | Blue8603F | Blue8613F | (H) | Blue8612F | Black8604T | 8617F |
| (1000ml) ASTM | GII AQL = | (AD) | (M) | (Y4) | (C) | ||||
| D5151-06 (2011) | 2.5 | ||||||||
| Lot size: | Holes | Holes | Holes | Holes | Holes | Holes | Holes | Holes | |
| 16,000 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | |
| Sample | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | |
| Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | ||
| Size: 80 | |||||||||
| TestASTM D6319-10 | ASTM | ||||||||
| 2. Length (mm) | D6319-10 | ||||||||
| SizeM | Min 230 | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 |
| 3. Palm width (mm) | |||||||||
| SizeM | |||||||||
| 95 + 10 | 95-97 | 97-99 | 95-97 | તેર-તેત્ર | 95-97 | 96-97 | 96-99 | 96-98 | |
| 4. Thickness (mm) | |||||||||
| (Single Layer) | |||||||||
| Finger | Min 0.05 | 0.10-0.12 | 0.09-0.11 | 0.10-0.12 | 0.09-0.12 | 0.11-0.14 | 0.08-0.10 | 0.13-0.16 | 0.10-0.12 |
| Palm | Min 0.05 | 0.07-0.08 | 0.06-0.07 | 0.06-0.07 | 0.06 | 0.06-0.07 | 0.06-0.07 | 0.10-0.12 | 0.06-0.08 |
| 5. PhysicalProperties | |||||||||
| Before Aging | |||||||||
| Tensile Strength | Min 14 | 25.90- | 25.59- | 25.09- | 23.14- | 23.33- | 24.64- | 20.51- | 22.70- |
| (MPa) | 32.06 | 31.07 | 30.66 | 29.50 | 29.02 | 28.78 | 23.75 | 29.88 | |
| Ultimate Elongation | Min 500 | 540-580 | 560-600 | 580-600 | 520-560 | 520-540 | 560-600 | 540-560 | 540-580 |
| (%) | |||||||||
| After Aging | |||||||||
| Tensile Strength | Min 14 | 28.40- | 26.54- | 30.72- | 26.53- | 28.04- | 24.14- | 23.81- | 23.90- |
| (MPa) | 33.92 | 32.19 | 37.60 | 33.17 | 33.98 | 28.78 | 31.78 | 31.77 | |
| Ultimate Elongation | Min 400 | 460-500 | 480-520 | 500-540 | 460-500 | 480-500 | 560-600 | 460-520 | 460-520 |
| (%) | |||||||||
| 6. Moisture Content(%) | Max 2.0% | 0.99% | 1.1% | 1.0% | 1.0% | 1.2% | 1.1% | 0.8% | 1.0% |
| Average | Average | Average | Average | Average | Average | Average | Average | ||
| 7. Residual Powder | Max 2.0mg/ | ||||||||
| ASTM-D6124-10 | glove | 0.20mg/ | 0.12mg/ | 0.10mg/ | 0.14mg/ | 0.16mg/ | 0.16mg/ | 0.16mg/ | 0.14mg/ |
| (Reapproved 2011) | glove | glove | glove | glove | glove | glove | glove | glove | |
| 8. Biocompatibility | ISO 10993- | Under the | Under the | Under the | Under the | Under the | Under the | Under the | Under the |
| Primary Skin | 10 | condition | condition | condition | condition | condition | condition | condition | condition |
| Irritation | Non-irritant | s of the | s of the | s of the | s of the | s of the | s of the | s of the | s of the |
| Dermal | Non- | study, | study, | study, | study, | study, | study, | study, | study, |
| Sensitization | sensitizer | the | the device | the | the device | the | the device | the | the |
| device is | is non- | device is | is non- | device is | is non- | device is | device is | ||
| non- | irritant or | non- | irritant or | non- | irritant or | non- | non- | ||
| irritant or | non- | irritant or | non- | irritant or | non- | irritant or | irritant or | ||
| non- | sensitizer | non- | sensitizer | non- | sensitizer | non- | non- | ||
| sensitizer | sensitizer | sensitizer | sensitizer | sensitizer | |||||
Performance data of gloves based on ASTM D6319-10 and FDA 1000ML water leak test
Sec 1 Sum Page 3 of 6
{6}------------------------------------------------
| 8.0 | Substantial Equivalence Comparison Table with Predicate Device, K052502 |
|---|---|
| ----- | ------------------------------------------------------------------------- |
| K142283 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Characteristics | BlueGlove8603F(AD) | BlueGlove8611F(M) | BlueGlove8603F(Y4) | BlueGlove8613F | BlueGlove8603(H) | BlueGlove8612F(C) | BlackGlove8604T | WhiteGlove8617F | Predicate K052502 | Medical GloveManual (1661) |
| Company Name | YTY Industry (Manjung) Sdn Bhd | YTY Industry(Manjung) Sdn Bhd | FDA | |||||||
| Product Name | Non-sterile, Powder Free Nitrile Examination [(8603F (AD) BlueColor, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F BlueColor, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T BlackColor and 8617F White Color] | Non-Sterile, OnLine Powder FreeNitrile Blue &White ColorExaminationGloves | PatientExaminationGloves | |||||||
| Product Code | LZA | LZA | LZA - (Polymer -other than Vinyl(includes Nitrile,Polyurethane, etc.) | |||||||
| Indication for Use | A patient examination gloves is a disposable device intended for medicalpurpose that is worn on the examiner's hand or fingers to preventcontamination between patient and examiner. | This is a medicalglove to be worn onthe hand of healthcare and similarpersonnel to preventcontam inationbetween health carepersonnel and thepatient. | Powder-FreeExaminationGlovesA powder-freepatientexamination gloveis a disposabledevice intendedfor medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | |||||||
| DeviceDescription | counter single use. | Non Sterile, Powder Free Nitrile Exam ination Gloves [(8603F (AD) BlueColor, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color,8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and8617F White Color] meets all the current specifications listed under theASTM Specification D6319-10, Standard Specification for NitrileExamination Gloves for Medical Application. This device is for over-the | Class 1 NitrilePatient ExaminationGlove 80 LZA,powder free thatmeets allrequirements ofASTM StandardD6319-00a63 andFDA water leaktest. | This gloves meetall currentspecificationslisted underASTMspecificationsD6319-10 | ||||||
| Over the CounterUse | This device is for over-the counter single use. | This device is forover-the countersingle use. | Indication for use | |||||||
| Single Use | Single Use | Single Use | Misbranding | |||||||
| Non Sterile orSterile | Non Sterile | Non Sterile | Sterilization | |||||||
| Powder Free | Powder Free | Powder Free | Process &Attribute labelin g | |||||||
| Compare materials | ||||||||||
| Materials | Carboxylated Butadiene Acrylonitrile | CarboxylatedButadieneAcrylon itrile | LZA - (Polymer -other than Vinyl(includes Nitrile,Polyurethane, etc.) |
{7}------------------------------------------------
| K142283 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BlueGlove8603F(AD) | BlueGlove8611F(M) | BlueGlove8603F(Y4) | BlueGlove8613F(FI) | BlueGlove8603(H) | BlueGlove8612F(C ) | BlackGloves8604T | WhiteGloves8617F | PredicateK052502 | MedicalGloveManual(1661) | |||||||
| Characteristics | ||||||||||||||||
| SpecificationsandPerformance | ||||||||||||||||
| TensileStrength beforeaging (MPa) | 25-59-31.07 | 25.59-31.07 | 25.09-30.66 | 23.14-29.50 | 23.33-29.02 | 24.64-28.78 | 20.51-23.75 | 22.70-29.88 | 26.00-30.00 | Current glovesmeet ASTMD6319-10 | ||||||
| TensileStrength afteraging (MPa) | 28.40-33.92 | 26.54-32.19 | 30.72-37.60 | 26.53-33.17 | 28.04-33.98 | 24.14-28.78 | 23.81-31.78 | 23.90-31.77 | 25.00-28.00 | Nitrile glovesASTMD6124-06 | ||||||
| (Reapproved2011)ResidualPowder | ||||||||||||||||
| UltimateElongationbefore aging(%) | 540-580 | 560-600 | 580-600 | 520-560 | 520-540 | 560-600 | 540-560 | 540-580 | 750-800 | |||||||
| UltimateElongation afteraging (%) | 460-500 | 480-520 | 500-540 | 460-500 | 480-500 | 560-600 | 460-520 | 460-520 | 670-730 | ASTMD5151-06(Reapproved2011) | ||||||
| DimensionsLength (mm) | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 | 240-251 | |||||||
| DimensionsWidth (mm) | 95-97 | 97-99 | 95-97 | 95-99 | 95-97 | 96-97 | 96-99 | 96-98 | 94-96 | Detection ofHoles inMedicalGloves | ||||||
| ThicknessFinger (mm) | 0.10-0.12 | 0.09-0.11 | 0.10-0.12 | 0.09-0.12 | 0.11-0.14 | 0.08-0.10 | 0.13-0.16 | 0.10-0.12 | 0.15-0.19 | |||||||
| Thickness Palm(mm) | 0.07-0.08 | 0.06-0.07 | 0.06-0.07 | 0.06 | 0.06-0.07 | 0.06-0.07 | 0.10-0.12 | 0.06-0.08 | 0.12-0.16 | |||||||
| AQL (As perFDArequirement) | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result:0 | MultipleNormalSamplingGIIAQL 2.5Lot size:16,000SampleSize: 80Acc: 5Rej: 6Result: 0 | |||||||
| ResidualPowder(mg/glove) | 0.99%Average | 1.1%Avg. | 1.0%Avg. | 1.0%Avg. | 1.2%Avg. | 1.1%Avg. | 0.8%Avg. | 1.0%Avg. | 0.20%Avg. | |||||||
| Size | M | M | M | M | M | M | M | M | M |
{8}------------------------------------------------
| Characteristics | BlueGlove8603F(AD) | BlueGlove8611F(M) | BlueGlove8603F(Y4) | BlueGlove8613F | K142283BlueGlove8603 (H) | BlueGlove8612F(C ) | BlackGloves8604T | WhiteGloves8617F | PredicateK052502 | MedicalGloveManual(1661) |
|---|---|---|---|---|---|---|---|---|---|---|
| Biocompatibility | Underthecondition of thestudy thedevice isnon-irritantand non-sensitizer | Underthecondition of thestudythedeviceis non-irritantandnon-sensitizer | Underthecondition ofthestudythedeviceisnon-irritantandnon-sensitizer | Underthecondition ofthestudythedeviceisnon-irritantandnon-sensitizer | Underthecondition of thestudy thedevice isnon-irritantand non-sensitizer | Underthecondition of thestudy thedevice isnon-irritantand non-sensitizer | Undertheconditionof thestudy thedevice isnon-irritantand non-sensitizer | Underthecondition of thestudythedevice isnon-irritantand non-sensitizer | Non-irritantNon-sensitizer | ISO 10993-10Skin IrritantDermal andSensitizationstudies |
| Labeling forlegallymarketedpredicate | -Powder Free-devicescolor:Clear(Blue)-PatientExaminationGlove-Non sterile-Single UseOnlyManufacturedFor:- Lot | Chapter 4 -Labeling |
9.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T Black Color and 8617F White Color] have the above technological characteristic compared to ASTM or Equivalent standards.
10.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the device. Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T Black Color and 8617F White Color] and the predicate device is substantially equivalent based on intended uses, physical properties, technological characteristics and nonclinical performance. This device is safe, effective, and performs as well as the predicate device.
Sec 1 Sum Page 6 of 6
§ 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.