(438 days)
The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves standard.
The provided text describes the acceptance criteria and the device performance, but does not contain a study designed to prove the device meets these criteria in the typical sense of a clinical or analytical study. Instead, the document is a 510(k) summary for a medical device (examination gloves), which establishes substantial equivalence to existing legally marketed devices based on non-clinical performance standards.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS (Acceptance Criteria) | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D3578-05(2010) | Meets standard requirements |
| Physical Properties | ASTM D3578-05(2010) | Meets standard requirements |
| Thickness | ASTM D3578-05(2010) | Meets standard requirements |
| Biocompatibility | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity Amendment 1:2006-07-15 | Pass (Not a primary skin irritant)Pass (Not a contact sensitizer) |
| Watertight (1000ml) | 21 CFR 800.20 | Pass |
Note regarding other criteria: The "Substantial Equivalence Comparison" table in section 9.0 also lists several characteristics with specific numerical requirements (e.g., Width, Length, Thickness, Tensile Strength, Elongation, Protein Content, Freedom from Holes). For the "Medtexx Manufacturing Sdn. Bhd." device, these are stated as meeting or passing the relevant ASTM or 21 CFR standards. For example:
- Width (Size Medium): Meets ASTM D 3578-05(2010): XS - 70 ± 10, S - 80 ± 10, M - 95 ± 10, L - 111 ± 10
- Overall length: Length ≥ 240mm
- Palm thickness: 0.08mm
- Finger thickness: 0.08mm
- Tensile Strength per aging min.: 18.0 MPa
- Tensile Strength after aging min.: 14.0 MPa
- Ultimate elongation pre aging min.: 650%
- Ultimate elongation after aging: 500%
- Residual powder test: Passes (meets applicable definition for Powder Free; $\le$ 2 mg per glove)
- Freedom from Holes: Meets Requirements per 21CFR800.20: Gloves Free of Holes at quality level of AQL 1.5
- Protein Content: Meets Applicable Definition for Protein Content; $\le$ max 50 (ug/dm²)
- Skin irritation: Passes
- Dermal sensitization: Passes
Study Details
The document states that "Clinical data is not needed for gloves or most devices cleared by the 510(k) process." This indicates that a traditional clinical study to "prove the device meets the acceptance criteria" was not conducted or required. Instead, the device's performance is demonstrated through compliance with established industry standards (ASTM, ISO) and FDA regulations (21 CFR). The basis for clearance is the "Substantial Equivalence" of the device to existing predicate devices, as shown by non-clinical performance data (i.e., laboratory testing against standards).
Given this, the following points address the specific questions based on the provided text, primarily indicating that these types of studies were not performed or are not applicable in this 510(k) context.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The document refers to "performance test data of non-clinical tests" but does not detail the sample sizes for these tests (e.g., how many gloves were tested for dimensions, physical properties, watertightness, biocompatibility, etc.).
- Data provenance: The submitting company, Worldmed Manufacturing Sdn. Bhd., is located in Malaysia. It is implied that the testing would have been conducted or overseen by the manufacturer or a contracted testing facility. The data itself would be considered retrospective in the sense that the tests were performed on manufactured glove samples to demonstrate compliance with standards for the 510(k) 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)
- Not applicable. For this type of device (examination gloves), ground truth is established by adherence to engineering and performance standards (e.g., ASTM, ISO, FDA regulations) as measured in laboratory settings, not by expert consensus on clinical observations. Therefore, no "experts" in the sense of clinical reviewers establishing ground truth are mentioned or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for studies where human interpretation or subjective assessment of data (e.g., medical images, clinical outcomes) is involved. The testing described for examination gloves involves objective physical and chemical measurements against predefined 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
- Not applicable. MRMC studies are used for evaluating diagnostic aids, especially in imaging, by comparing human readers' performance with and without assistance from a device. This is a very different type of device (examination gloves) where such a study design is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an examination glove, not an algorithm or a diagnostic tool that would have "standalone" performance in the context of AI or interpretive systems. Its performance is inherent to its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is the defined specifications and limits within the referenced national and international standards (ASTM D3578-05(2010), ISO 10993-10:2002/Amd 1:2006(E), 21 CFR 800.20). Performance is judged by whether the device's measured characteristics meet these established engineering and material science criteria.
- For biocompatibility, the "ground truth" is established by laboratory tests for irritation and sensitization, with "Pass" indicating no adverse biological reactions as defined by the ISO standard.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device.
In summary: The provided text details how the examination gloves meet established engineering and biocompatibility standards through non-clinical laboratory testing. The basis for FDA clearance is "substantial equivalence" to predicate devices, not a clinical study proving effectiveness or safety in human subjects.
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Powder Free Natural Rubber Latex Examination Gloves
Attachment 17
510(k) SUMMARY
1.0 Submitter :
| Name | Worldmed Manufacturing Sdn. Bhd. |
|---|---|
| Address | Lot 18873, Kamunting Industrial Estate34600 Taiping, Perak,Malaysia. |
| Phone No. | 605-892 5555 |
| Fax No. | 605-829 5590 |
| Contact Person | Chandrasegaran (Mr) |
Date of Preparation : May 14, 2012
SEP 06 2013
2.0 Name of the Device
Powder Free Natural Rubber Latex Examination Gloves
| Common Name : | Patient Examination Gloves |
|---|---|
| Classification Name : | Patient Examination Gloves |
| 510(K) Number : | K121844 |
Identification of The Legally Marketed Devices That equivalency is claimed: 3.0
Primary Predicate:
MPXX™ Powder Free Natural Rubber Latex Examination Gloves Company : Total Glove Company Sdn Bhd. 510(K) : K110250
Additional Predicate:
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile Company : Wear Safe (Malaysia) Sdn. Bhd. 510(K) : K101799
4.0 Description of the Device:
The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves standard.
5.0 Intended Use of the Device
The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
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Summary of the Technological Characteristics of the Device: 6.0
The Powder Free Natural Rubber Latex Examination are summarized with the following technological characteristics compared to ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D3578-05(2010) | Meets standard requirements |
| Physical Properties | ASTM D3578-05(2010) | Meets standard requirements |
| Thickness | ASTM D3578-05(2010) | Meets standard requirements |
| Biocompatibility | ISO 10993-10:2002/Amd1:2006(E) Biologicalevaluation of medicaldevices - Part 10: Tests forirritation and delayed-typehypersensitivityAmendment 1:2006-07-15ISO 10993-10:2002/Amd1:2006(E) Biologicalevaluation of medicaldevices - Part 10: Tests forirritation and delayed-typehypersensitivityAmendment 1:2006-07-15 | Pass (Not a primary skinirritant)Pass (Not a contact sensitizer) |
| Watertight (1000ml) | 21 CFR 800.20 | Pass |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 7.0
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0
Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
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Substantial Equivalence Comparison 9.0
| Characteristicandparameters | MedtexxManufacturing Sdn.Bhd. | Total GloveCompany Sdn.Bhd.K110250 | Wear Safe(Malaysia) Sdn.Bhd.K101799 | SubstantialEquivalence(SE) |
|---|---|---|---|---|
| Product Code | 80LYY | 80LYY | 80LYY | |
| Intended use | The Powder FreeNatural Rubber LatexExamination Gloves isa single use disposabledevice intended formedical purposes thatis worn on the hands ofhealthcare and similarpersonnel to preventcontamination betweenthe healthcarepersonnel and thepatient. | MPXX™ PowderFree NaturalRubberExaminationGloves is a singleuse deviceintended formedical purposesthat is worn on thehand of healthcareand similarpersonnel topreventcontaminationbetweenhealthcarepersonnel and thepatient. | Powder FreeNatural RubberLatex ExaminationGloves, Blue Color,Non-Sterile is adisposable deviceintended formedical purposethat is intended tobe worn on thehand for medicalpurposes to providebarrier againstpotentiallyinfectious materialsand othercontamination | SE |
| Width (SizeMedium) | Meets ASTM D 3578-05(2010):XS - 70 ± 10S - 80 ± 10M - 95 ± 10L - 111 ± 10 | Meets ASTM D3578-05 | Meets ASTM D3578-05 | SE |
| Overall length | -Length ≥ 240mm | -Length ≥ 240mm | Meets ASTM D3578-05 | SE |
| Palm thickness | 0.08mm | 0.08mm | Meet ASTM D3578-05 | SE |
| Finger thickness | 0.08mm | 0.08mm | Meet ASTM D3578-05 | |
| Tensile Strengthper aging min. | 18.0 MPa | Meets ASTM D3578-05: | Meet ASTM D 412 | |
| Tensile Strengthafter aging min | 14.0 MPa | - Tensile Strength≥ 18MPa (≥18MPa perStandard ) | Meet ASTM D 412 | |
| Ultimateelongation preaging min | 650% | Meets ASTM D3578-05: | Meet ASTM D 412 | |
| Ultimateelongation afteraging | 500% | - Elongation ≥650% | Meet ASTM D 412 | |
| MeetsBiocompatibility | Yes | Yes | Yes | SE |
| Duration of bio-compatibility | Limited | Limited | Limited | |
| Skin irritation | Passes | Passes | Not a primary skin irritant | |
| Dermal sensitization | Passes | Passes | Not a contact skin sensitizer | |
| Residual powder test | Passes | Meets Applicable Definition for PowderFree; $\le$ 2 mg per glove | Meets ASTM D 6124-06 | |
| Freedom from Holes | Meets Requirements per 21CFR800.20:Gloves Free of Holes at quality level of AQL 1.5(AQL 2.5 required per standard) | Meets Requirements per 21CFR800.20:Gloves Free of Holes at quality level of AQL 1.5(AQL 2.5 required per standard) | Meets ASTM D 5151-06 | Yes, SE |
| Materials | Natural Rubber Latex | Natural Rubber Latex | Natural Rubber Latex | Yes, Substantial Equivalence |
| Protein Content | Meets Applicable Definition for Protein Content; $\le$ max 50 (ug/dm²) | Meets Applicable Definition for Protein Content; $\le$ max 50 (ug/dm²) | Meets ASTM D 5712-05 | Yes, Identical |
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Powder Free Natural Rubber Latex Examination Gloves
Attachment 17
10.0 Conclusion
.
ﮯ
Powder Free Natural Rubber Latex Examination Gloves will perform according to the gloves performance standards referenced in section 6.0 above and meets 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/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
September 6, 2013
WorldMed Manufacturing Sdn. Bhd. Mr. Chandrasegaran Unite Head, Quality Assurance & Regulatory Affairs Lot 18873. Jalan Perusahaan 3. Kamunting Industrial Estate Kamunting Perak MALAYSIA 34600
Re: K121844
Trade/Device Name: Powder Free Natural Rubber Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 6, 2013 Received: August 12, 2013
Dear Mr. Chandrascgaran:
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.
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Page 2 - Mr. Chandrasegaran
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 (OS) 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/MedicalDevices/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Image /page/5/Picture/7 description: The image shows a signature and contact information. The text "Sincerely yours" is at the top left of the image. Below the signature, the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID" is present.
Kwame Ulmer M.S. Acting Division 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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Powder Free Natural Rubber Latex Examination Gloves
Attachment 2
ﮯ
| INDICATIONS FOR USE |
|---|
| --------------------- |
Applicant : WORLDMED MANUFACTURING SDN. BHD. LOT 18873, Kamunting Industrial Estate, 34600 Talping, Perak, Malaysia. 510(k) Number : K121844 (if known) POWDER FREE NATURAL RUBBER Device Name : LATEX EXAMINATION GLOVES Indications For Use :
The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient
| Prescription Use | OR Over-The-Counter | X |
|---|---|---|
| Per 21 CFR 801.109 | ||
| Steven T. Elliott S Division Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices | ||
| Oignally signed by Steven T. Elliott -S DN: cn=Steven T. Elliott -S, o=U.S. Government, ou=HHS, ou=FDA, ou=People, email=steven.elliott@fda.hhs.gov 0.9.2342.19200300.100.1.1=2000375530. cn=Steven T. Elliott -S Date: 2013.09.05 11:17:13 -04'00' | ||
| 510(k) Number: K121844 |
§ 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.