(336 days)
A 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.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous; i.e. can be worn on right hand or left hand.
The provided 510(k) summary (K132354) describes the acceptance criteria and performance of a Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile. This device is a medical glove, and its evaluation relies on established ASTM (American Society for Testing and Materials) standards and FDA regulations, rather than clinical studies involving human or expert readers.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance (K132354) |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets (Length min 230mm, Width min 95±10) |
| Physical Properties | ASTM D6319-10 | Meets: - Before Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 500% - After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400% |
| Thickness | ASTM D6319-10 | Meets (Finger min 0.05mm, Palm min 0.05mm) |
| Powder Free | ASTM D6124-06 (Reapproved 2011) | Meets (≤ 2 mg/glove) |
| Biocompatibility | Primary Skin Irritation: ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Passes (Not a primary skin irritant - PII of test material "0"; no erythema or oedema noted) |
| Dermal Sensitization: ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) | Passes (Not a contact sensitizer; no positive allergic reaction observed during challenge phase) | |
| Watertight | ASTM D5151-06 (Reapproved 2011) | Passes (AQL 2.5) |
| Intended Use | A 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. | |
| Material | ASTM D6319-10 | Nitrile, Sulphur, Zinc Oxide, Zinc Dibutyldithiocarbamate (ZDBC), Zinc Diethyldithiocarbamate (ZDEC), Phenolic Antioxidant, Titanium Dioxide, Blue Pigment |
| Color | - | Blue |
| Texture | - | Finger textured |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
Study Details:
This submission is for a medical glove, not an AI or imaging diagnostic device. Therefore, many standard questions related to studies involving human readers, AI algorithms, and complex ground truth establishment are not applicable. The device's performance is demonstrated through adherence to recognized physical, chemical, and biological standards.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for dimensions, physical properties, etc.).
- Data Provenance: The tests are based on established ASTM standards and ISO guidelines, suggesting controlled laboratory testing environments. The country of origin of the data is not explicitly stated beyond the Malaysian address of the submitter, implying the testing was either conducted in Malaysia or contracted to a lab adhering to international standards. The data is retrospective in the sense that it represents the results of finished product testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for medical gloves is not established by human experts in the same way it would be for a diagnostic imaging device. Instead, ground truth is defined by the objective measurements and parameters outlined in the ASTM and ISO standards (e.g., a glove is watertight if it passes the AQL 2.5 leakage test, not based on an expert's opinion).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for subjective assessments or ambiguous cases, commonly found in diagnostic imaging or clinical trials. For glove performance, the standards dictate objective pass/fail criteria.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic tasks.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or an AI system. Its performance is inherent in its physical and material properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device is defined by objective physical, chemical, and biocompatibility standards and measurements as specified by ASTM (e.g., D6319-10 for physical characteristics, D6124-06 for powder residue, D5151-06 for watertightness) and ISO (e.g., 10993-10:2010(E) for biocompatibility).
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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510(K) summary Page 1 of 5
510(k) SUMMARY
JUN 3 0 2014
1.0 Submitter:
| Name: | Mr. Francis V |
|---|---|
| Address: | Advanced Healthcare Products Sdn BhdLot 60 & 61, Lorong Senawang 3/2,Senawang Industrial Estate,70450 Seremban, Negeri Sembilan Darul Khusus,Malaysia. |
| Phone No.: | +60 6 678 4188 |
| Fax No.: | +60 6 678 4727 |
Date of Summary Prepared: June 27, 2014
LZA)
2.0 Name of the device:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile
Common Name: Patient Examination Glove Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code
Regulatory Class I
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile (and various brandnames) 510(k) : K110979 MDL : D133849 Regulatory Class I Product Code : LZA
4.0 Description of The Device:
| PredicateK110979 | CurrentK132354 |
|---|---|
| Dermagrip Ultra Powder Free BlueNitrile Patient Examination GlovesNon-Sterile (and various brandnames)meets all the requirements of ASTMstandard D6319-10 and FDA 21 CFR880.6250. | Powder Free Blue Nitrile PatientExamination Glove, Non-Sterile meetsall the requirements of ASTM standardD6319-10 and FDA 21 CFR 880.6250. |
| The powder free nitrile examinationglove is manufactured from syntheticrubber latex. Inner surface of glovesundergo surface treatment process toproduce a smooth surface that assiststhe user in donning the gloves with easewithout using any lubricant such aspowder on the glove surface. The gloveis ambidextrous; i.e. can be worn onright hand or left hand. |
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5.0 Intended Use of the Device:
A 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| PredicateK110979 | CurrentK132354 | ||
| Dimensions | ASTM D6319-10 | Meets | MeetsLength min 230mmWidth min 95±10 |
| Physical Properties | ASTM D6319-10 | Meets | MeetsBefore AgingTensile Strengthmin 14 MPaUltimate ElongationMin 500%After AgingTensile Strength min 14MPaUltimate ElongationMin 400% |
| Thickness | ASTM D6319-10 | Meets | MeetsFinger min 0.05mmPalm min 0.05mm |
| Powder Free | ASTM D6124-06(Reapproved 2011) | Meets≤ 2 mg/glove | Meets≤ 2 mg/glove |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| PredicateK110979 | CurrentK132354 | ||
| Biocompatibility | Primary SkinIrritation -ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, ChapterII, Part 1500 | Passes(Not a primaryskin irritant)There was noerythema oroedema noted onabraded or non-abraded sites at$24\pm1$ hours and$72\pm1$ hours. ThePrimary IrritationIndex (PII) of testmaterial was "0". | Passes(Not a primary skinirritant)There was noerythema or oedemanoted on abraded ornon-abraded sites at$24\pm1$ hours and $72\pm1$hours. The PrimaryIrritation Index (PII)of test material was"0". |
| DermalSensitization -ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, ChapterII, Part1500.3(c)(4) | Passes(Not a contactsensitizer)There was nopositive allergicreaction observedduring thechallenge phase(at $0\pm2$ , $24\pm2$hours and $48\pm2$hours) in animalstreated with thetest material andnegative control. | Passes(Not a contactsensitizer)There was no positiveallergic reactionobserved during thechallenge phase (at$0\pm2$ , $24\pm2$ hours and$48\pm2$ hours) inanimals treated withthe test material andnegative control. | |
| Watertight (1000ml) | ASTM D5151-06(Reapproved 2011) | Passes | PassesAQL 2.5 |
| Intended Use | The powder freeexamination gloveis a specialtymedical glovewhich is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or forefingerto preventcontaminationbetween examinerand patient bodilyfluids, waste orenvironment. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | |
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | ||
| PredicateK110979 | CurrentK132354 | ||
| Material | ASTM D6319-10 | Nitrile | NitrileSulphurZinc OxideZincDibutyldithiocarbamate (ZDBC)ZincDiethyldithiocarbamate(ZDEC).Phenolic AntioxidantTitanium DioxideBlue Pigment |
| Color | - | Blue | Blue |
| Texture | - | Finger textured | Finger textured |
| Size | Medical GloveGuidance Manual -Labeling | SmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical GloveGuidance Manual -Labeling | Single use | Single use |
| Manufacturer(s) | - | Advance MedicalProducts Sdn Bhd | Advanced HealthcareProducts Sdn Bhd |
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AHP 510K Summary K132354 Page 3 of 5
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7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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9.0 Conclusion
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards such as ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract bird or eagle in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Advanced Healthcare Products Sdn Bhd Mr. Francis V Operations Manager Lot 60 & 61, Lorong Senawang 3/2 Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, MALAYSIA
Re: K132354
·
Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 20, 2014 Received: May 22, 2014
Dear Mr. Francis V:
We have reviewed your Section 510(k) promarket 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 docs 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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Page 2 - Mr. Francis V
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance 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 Purofitt-Sheth, M.D. Cliaical 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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known) K 132354
Device Name
Powder Free Blue Nitrile Patient Examination Glove Non-Sterile
Indications for Use (Describe)
A 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)
0 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gutala
.. ::
.
Digitally signed by Sreekanth Gutala -5 DN; coUS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -5 Date: 2014,06.23 13:54:11 -04Y00'
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FORM FDA 3881 (1/14)
§ 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.