← Product Code [LZA](/productcode/LZA) · K132484 # DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K132484) _Wrp Asia Pacific Sdn. Bhd. · LZA · Dec 13, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K132484 ## Device Facts - **Applicant:** Wrp Asia Pacific Sdn. Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Dec 13, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for 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. ## Device Story Dermagrip Powder Free Black Nitrile Patient Examination Gloves are non-sterile, single-use synthetic rubber latex gloves. Designed for use by healthcare professionals during patient examinations to provide a barrier against contamination. The gloves are ambidextrous and feature a finger-textured surface for grip. The inner surface undergoes a treatment process to facilitate easy donning without the use of powder lubricants. The device is used in clinical settings; it functions as a physical barrier. Benefits include protection for both the examiner and the patient by reducing the risk of cross-contamination during medical procedures. ## Clinical Evidence No clinical data. Bench testing only, including ASTM D6319-10 compliance for dimensions, physical properties, and thickness; ASTM D6124-06 for powder content; ASTM D5151-06 for water leak/watertightness; and ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization). ## Technological Characteristics Synthetic nitrile rubber; powder-free; finger-textured; ambidextrous. Complies with ASTM D6319-10 (dimensions, physical properties, thickness), ASTM D6124-06 (powder content), and ASTM D5151-06 (watertightness). Biocompatibility per ISO 10993-10. Non-sterile. ## Regulatory 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. ## Predicate Devices - Dermagrip-N Powder Free Blue Nitrile Examination Gloves ([K022904](/device/K022904.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ DEC 13 2013 # 510(k) SUMMARY #### 1.0 Submitter: | Name: | Mr. Kirk Penner | |------------|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | WRP Asia Pacific Sdn Bhd
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,
43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | Date of Summary Prepared: 25 July 2013 #### 2.0 Name of the device: Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) ## 3.0 Identification of The Legally Marketed Devices that equivalency is claimed: Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA ### 4.0 Description of The Device: Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. 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. #### 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. {1}------------------------------------------------ # 510(k) SUMMARY ## 6.0 Summary of the Technological Characteristics of the Device: The Powder Free Black Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate | Current | | Name | - | Dermagrip-N
Powder Free
Blue Nitrile
Examination
Gloves | Dermagrip
Powder Free
Black Nitrile
Patient
Examination
Gloves, Non-
Sterile | | Sterility status | ISO11137-1:2006 | Non-Sterile | Non-Sterile | | Dimensions | ASTM D6319-10 | Meets | Meets | | Physical Properties | ASTM D6319-10 | Meets | Meets | | Thickness | ASTM D6319-10 | Meets | Meets | | Powder Free | ASTM D6124-06 | Meets
< 2 mg/glove | Meets
< 2 mg/glove | | Biocompatibility | Primary Skin
Irritation -
ISO 10993-
10:2002(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter II,
Part 1500 | Passes
(Not a primary
skin irritant)
The Primary
Irritation Index
was "0.125". | Passes
(Non Primary
Irritant)
There was no
erythema or
oedema noted
on abraded or
non-abraded
sites at 24±1
hours and 72±1
hours after
application. The
Primary
Irritation Index
(PII) of test
material was
"0". | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | | | Predicate | Current | | Dermal Sensitization | ISO 10993-
10:2002(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter II,
Part 1500.3(c)(4) | Passes
(Not a contact
sensitizer)
There was no
positive allergic
reaction
observed during
the challenge
phase (at 24
hours and 48
hours) among
the tested
material and
the negative
control. | Passes
(Not a contact
sensitizer)
There was no
positive allergic
reaction
observed during
the challenge
phase (at 0±2,
24±2 hours and
48±2 hours) in
animals treated
with the test
material and
negative
control. | | Watertight (1000ml) | ASTM D5151-06 | Passes | Passes | | Intended use | - | The powder free
blue Nitrile
examination
glove, non-
sterile is a
disposable
device and is
made of
synthetic rubber
intended for
medical
purposes that is
worn on the
examiner's
hand or finger
to prevent
contamination
between patient
and examiner. | 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 | Nitrile | | Color | - | Blue | Black | | Texture | - | Finger textured | Finger textured | | Size | Medical Glove
Guidance Manual -
Labeling | Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | | Single Use | Medical Glove
Guidance Manual -
Labeling | Single use | Single use | | Manufacturer(s) | - | WRP Asia Pacific
Sdn Bhd | WRP Asia Pacific
Sdn Bhd | WRP Summary, Section D, K132484, Page 2 of 4 {2}------------------------------------------------ # 510(k) SUMMARY . ' . • {3}------------------------------------------------ # 510(k) SUMMARY There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for color and thickness. The current device is black in color and thinner than the predicate device, however it meets the ASTM standards. ## 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. #### 9.0 Conclusion Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is safe, effective and substantially equivalent to currently marketed devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle. Public Health Service Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 13, 2013 Mr. Kirk Penner Head of Department Product Management & Regulatory Affairs WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan MALAYSIA 43900 Re: K132484 Trade/Device Name: Dermagrip Powder Free Black Nitrile Patient Examination Gloves Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 28, 2013 Received: November 1, 2013 Dear Mr. Penner: 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 {5}------------------------------------------------ Page 2 - Mr. Penner 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. 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/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/ResourcesforYou/Industry/default.htm. Sincerely yours. Image /page/5/Picture/8 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The logo is black and white and has a stylized design. The text is arranged in a triangular shape, with the name at the top and the title below. The word "DAGRID" is at the bottom of the triangle. The word "FOR" is at the bottom right of the image. Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # 3-4-4-4-6-11-6-14-1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K 132484 ## Device Name Dermagrip Powder Free Black Nitrile Patient Examination Gloves Non-Sterile # Indications for Use (Describe) A patient contention 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) Over-The-Counter Use (21 CFR 601 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A REMOVE THE INSTRUCTIONS ABOVE THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.1751 1883 1 FOR FDA USE ONLY. BE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) -05'00 Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. Page for f FORM FDA 3881 (9/13) --- **Source:** [https://fda-staging.innolitics.com/device/K132484](https://fda-staging.innolitics.com/device/K132484) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com