(438 days)
Not Found
No
The device is a standard examination glove and the summary does not mention any AI/ML components or capabilities.
No
The device, examination gloves, is intended to prevent contamination between healthcare personnel and the patient. It does not exert any direct therapeutic effect on a disease or condition.
No
The device is described as examination gloves used to prevent contamination, not to diagnose a condition.
No
The device is a physical product (gloves) and the summary describes physical properties and performance tests related to a tangible item, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for "medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D3578-05(2010)), which are relevant to their function as a barrier, not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information
- Reagents or assay components
The information provided describes a medical device used for personal protection and infection control, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Estate |
| 34600 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.
1
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/Amd | |
| 1:2006(E) Biological | ||
| evaluation of medical | ||
| devices - Part 10: Tests for | ||
| irritation and delayed-type | ||
| hypersensitivity | ||
| Amendment 1:2006-07-15 | ||
| 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 |
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.
2
Substantial Equivalence Comparison 9.0
| Characteristic
and
parameters | Medtexx
Manufacturing Sdn.
Bhd. | Total Glove
Company Sdn.
Bhd.
K110250 | Wear Safe
(Malaysia) Sdn.
Bhd.
K101799 | Substantial
Equivalence
(SE) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | 80LYY | 80LYY | 80LYY | |
| Intended 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. | MPXX™ Powder
Free Natural
Rubber
Examination
Gloves is a single
use device
intended for
medical purposes
that is worn on the
hand of healthcare
and similar
personnel to
prevent
contamination
between
healthcare
personnel and the
patient. | Powder Free
Natural Rubber
Latex Examination
Gloves, Blue Color,
Non-Sterile is a
disposable device
intended for
medical purpose
that is intended to
be worn on the
hand for medical
purposes to provide
barrier against
potentially
infectious materials
and other
contamination | SE |
| Width (Size
Medium) | Meets ASTM D 3578-
05(2010):
XS - 70 ± 10
S - 80 ± 10
M - 95 ± 10
L - 111 ± 10 | Meets ASTM D
3578-05 | Meets ASTM D
3578-05 | SE |
| Overall length | -Length ≥ 240mm | -Length ≥ 240mm | Meets ASTM D
3578-05 | SE |
| Palm thickness | 0.08mm | 0.08mm | Meet ASTM D
3578-05 | SE |
| Finger thickness | 0.08mm | 0.08mm | Meet ASTM D
3578-05 | |
| Tensile Strength
per aging min. | 18.0 MPa | Meets ASTM D
3578-05: | Meet ASTM D 412 | |
| Tensile Strength
after aging min | 14.0 MPa | - Tensile Strength
≥ 18MPa (≥
18MPa per
Standard ) | Meet ASTM D 412 | |
| Ultimate
elongation pre
aging min | 650% | Meets ASTM D
3578-05: | Meet ASTM D 412 | |
| Ultimate
elongation after
aging | 500% | - Elongation ≥
650% | Meet ASTM D 412 | |
| Meets
Biocompatibility | 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 Powder
Free; $\le$ 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 |
3
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.
4
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.
5
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
6
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 |