(184 days)
K/DEN numbers are not present in the "Reference Device(s)" section of the provided text.
No
The 510(k) summary describes standard nitrile examination gloves and makes no mention of AI or ML technology.
No
The device is described as an examination glove to prevent contamination, not to treat or cure a medical condition.
No
The device is a glove for examination purposes, it does not diagnose any conditions or diseases.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand for medical purposes to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material and specifications for a glove, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Nitrile Exam Gloves, Powder Free, Black, Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing performed per ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-10.
Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K113440
510 (k) Summary NITRILE EXAM GLOVES, POWDER FREE, BLACK
| 1.0 | Submitter's Name | : | Central Medicare Sdn. Bhd. |
|---|---|---|---|
| 2.0 | Submitter's Address | : | PT 2609-2620 Bt 8, Jalan Changkat Jong |
| Mukim Changkat Jong | |||
| 36000 Teluk Intan, Perak | |||
| Malaysia. | |||
| 3.0 | Telephone No. | : | 605-6231220 |
| 4.0 | Fax No. | : | 605-6231230 |
| 5.0 | Contact Person | : | Mr. K. F Cheong |
| 6.0 | Date of Preparation | : | 18th Nov 2011 |
| 7.0 | Name of Device | : | Nitrile Exam Gloves, Powder Free, Black |
| Size | Model Number |
|---|---|
| Small | N641 |
| Medium | N642 |
| Large | N643 |
| Extra Large | N644 |
| Extra X-Large | N645 |
| Proprietary/Trade Name: | Nitrile Exam Gloves, Powder Free |
|---|---|
| Other clients private labeling | |
| Common Name | Nitrile Examination Glove |
| Classification Name | Patient Examination Glove |
| Device Classification | I |
| Regulation Number | 21 CFR 880.6250 |
| Product Code | LZA |
8.0 Identification of The Legally Marketed Device:
The Nitrile Exam Gloves, Powder Free, Black Class I patient examination gloves, Nitrile-80 LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate device: Blue Nitrile Examination Gloves, Powder Free (K093696) Powder Free Nitrile Examination Gloves White Colored (K103734)
9.0 Description of Device:
The Nitrile Exam Gloves, Powder Free, Black, Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
: : .. .
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Intended Use of the Device: 10.0
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
11.0 Summary of The Technological Characteristics of New Device Compared to The Predicate Device:
There is no different technology characteristic. Gloves are made from nitrile compound (dispersion of butadiene acrylonitrile copolymer) and the initial products are powder free nitrile examination gloves. The Nitrile Exam Gloves, Powder Free, Black possesses the following technological characteristic {as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 412-98 (Reapproved 2002) | Meets |
| Freedom From pin-holes | ASTM D 5151-06 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Dermal Sensitization in the guinea pig | |
| (as per ASTM F 720-81(Reapproved | ||
| 2007)) | Passes | |
| Not a Dermal Sensitization | ||
| Primary Skin Irritation Test in rabbits | ||
| (as per Consumer Product Safety | ||
| Commission, Title 16, Chapter II, Part | ||
| 1500.3 & 1500.41) | Passes | |
| Not a Primary Skin irritant |
12.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Testing performed per ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-10.
Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
13.0 Brief description of Clinical Tests
No new clinical tests were conducted under this 510(k).
Conclusions Drawn from the Non-Clinical and Clinical Tests. 14.0
It can be concluded that the Nitrile Exam Gloves, Powder Free, Black meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL, meet labeling claims. It is as safe as effective, and performed as well the legally marketed indentified in clause 8.0.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Central Medical Sdn Bhd C/O Mr. Nicholas Wang Senior Vice President Encompass Medical Supplies 1930 Brea Canyon Road #240 Diamond Bar, California 91765
MAY 2 3 2012
Re: K113440
Trade/Device Name: Nitrile Powder-Free Black Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 17, 2012 Received: April 20, 2012
Dear Mr. Wang:
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. Wang
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Sincerely vours.
Anthony O. an
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Applicant :
Central Medicare Sdn. Bhd.
510(k) Number (if known):
Device Name:
Nitrile Exam Gloves, Powder Free, Black
| Size | Model Number |
|---|---|
| Small | N 641 |
| Medium | N 642 |
| Large | N 643 |
| Extra Large | N 644 |
| Extra X-Large | N 645 |
Indication For Use:
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Elliott Bellamie- Webb
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113440