← Product Code [LZA](/productcode/LZA) · K122408 # POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) (K122408) _Hongye Plastic Products Co., Ltd. · LZA · Jan 17, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K122408 ## Device Facts - **Applicant:** Hongye Plastic Products Co., Ltd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Jan 17, 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 disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. ## Device Story Disposable, non-sterile nitrile examination gloves (black, white, green) worn by healthcare examiners on hands or fingers. Function as a protective barrier to prevent contamination between patient and examiner. Used in clinical settings. No specialized operation required. Benefit is reduction of cross-contamination risk during medical examinations. ## Clinical Evidence No clinical data. Bench testing only, including physical property testing (tensile strength, elongation), dimension measurements, freedom from pinholes, residual powder testing (ASTM D6124), and biocompatibility (primary skin irritation and dermal sensitization per ISO 10993-10). ## Technological Characteristics Nitrile compound examination gloves. Meets ASTM D6319-10 standards for physical properties, dimensions, and freedom from pinholes. Biocompatibility per ISO 10993-10, 16CFR 1500.41, and 16CFR 1500.3. Non-sterile, powder-free. Available in black, white, and green. ## 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 - Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue ([K070861](/device/K070861.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}------------------------------------------------ ## Hongve Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000 EXHIBIT #1 Page 1 of 4 ## 510(K) SUMMARY ## JAN 1 7 2013 This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(K) number is: _ < \ 2 乙 イ ○ 8 ## 1. Owner's Identification: Ms. Liu Yingxue Hongye Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, China 050000 Tel: 86-311-83980319 Submitter and Contact person: Kathy Liu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: July 30, 2012 Date Summary Prepared: July 30, 20. ## 2. Name of the Device: Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves (Black, White, Green) Common Name: Exam Gloves #### 3. Predicate Device Information: Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10. ### 5. Intended Use of the Device: A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. {1}------------------------------------------------ # Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000 ## EXHIBIT #1 Page 2 of 4 ## 6. Comparison to Predicate Devices: Comparison to I regicate Doriees: Portecel Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Black, Holly, I hastic Products Ook, B&I B Lear B and effectiveness to the Hong Xin Wilte, Green) is Substantially ouder Free Nitrile Examination Gloves, Blue. | Characteristics | Standard | Device Performance | | Result of
comparison | | |--------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------| | | | Predicate device | Subject Device | | | | Product Code | / | LZA | LZA | Substantial
equivalence | | | Intended Use | / | Predicate device
is disposable
non-sterile
device intended
for medical
purpose that is
worn on the
examiner's hand
or finger to
prevent
contamination
between patient
and examiner. | Subject device is
disposable non-
sterile device
intended for
medical purpose
that is worn on
the examiner's
hand or finger to
prevent
contamination
between patient
and examiner. | Substantial
equivalence | | | Labeling | / | There are no
special labeling
claims and do
not claim gloves
as
hypoallergenic
on labels. | There are no
special labeling
claims and do
not claim gloves
as
hypoallergenic
on labels. | Substantial
equivalence | | | Device Materials | / | Nitrile
compound
Blue | Nitrile
Compound
Black, White,
Green | Substantial
equivalence | | | Color | / | | | Different, it
have been
confirmed to
be safety for
use | | | Device
tolerances and
specifications | Tensile
strength:
before and
after aging | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | Characteristics | Standard | Device Performance | | Result of comparison | | | Device
tolerances and
specifications | Ultimate
elongation:
before and
after aging | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Freedom
from pinholes | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Dimensions:
Overall
length,
Width, Palm
and Finger
thickness | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Residual
powder | ASTM
D6319-10,
ASTM
D6124 | Meets | Meets | Substantial
equivalence | | Performance
data | Tensile
strength:
before and
after aging | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Ultimate
elongation:
before and
after aging | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Freedom
from pinholes | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Dimensions:
Overall
length,
Width, Palm
and Finger
thickness | ASTM
D6319-10 | Meets | Meets | Substantial
equivalence | | | Residual
powder | ASTM
D6319-10
&
ASTM
D6124 | Meets | Meets | Substantial
equivalence | | | | Device Performance | | Result of | | | Characteristics | Standard | Predicate device | Subject Device | comparison | | | Biocompatibility | Primary
skin
irritation
test | Passes
Not a primary
skin irritation | Passes
Not a primary
skin irritation | Substantial
equivalence | | | | Dermal
sensitization
assay | Passes
Not a dermal
sensitization | Passes
Not a dermal
sensitization | Substantial
equivalence | | {2}------------------------------------------------ Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000 . : ## EXHIBIT #1 Page 3 of 4 . . {3}------------------------------------------------ # Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000 ## EXHIBIT #1 Page 4 of 4 # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: | Characteristics | Applicable FDA- Recognized Standards | Performance Results | |---------------------------------------------------|----------------------------------------------------|---------------------| | Dimensions | ASTM D 6319-10 | Meets | | Physical Properties | ASTM D 6319-10 | Meets | | Freedom from holes | ASTM D 6319-10 | Meets | | Residual Powder Test | ASTM D 6319-10
ASTM D6124-06 (Reapproved 2011) | Meets | | Primary Skin Irritation
and Skin Sensitization | ISO 10993 Part 10
16CFR 1500.41
16CFR 1500.3 | Meets | #### 8. Labeling: There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels. # 9. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. #### 10. Conclusions: Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Black, White, Green) conform fully to ASTM D6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, applicable 21 Of References and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial I hele are no'salecty/cricacy ibacases of the complete list of non-clinical tests, the oquiralerse - predioned is as safe and effective as the predicate device. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### January 17, 2013 Hongye Plastic Products Company, Limited C/O Ms. Kathv Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue CHINO CA 91710 Re: K122408 Trade/Device Name: Powder Free Nitrile Examination Gloves (Black, White, Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 26, 2012 Received: November 27, 2012 Dear Ms. Liu: 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}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Anthong Lo nina Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000 Attachment A # INDICATION FOR USE K 199408 510 (k) NUMBER (IF KNOW): Hongye Plastic Products Co., Ltd. APPLICANT: Powder Free Nitrile Examination Gloves (Black, DEVICE NAME: White, Green) #### INDICATIONS FOR USE: A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR Over-The-Counter-Use (21CFR 801Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) | Elizabeth F. Claverie | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 2013.01.16 ,14:53:22 2 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 | | | Division Sign-Off) | Page 1 of 1 | | Division of Anestheslology, General Hospital
. | | 510(k) Number: K122408 --- **Source:** [https://fda-staging.innolitics.com/device/K122408](https://fda-staging.innolitics.com/device/K122408) **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