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FDA 510(k)

ERGO II, SURGICAL LATEX GLOVES

K-Number: K884030 · 1988-11-07

ApplicantErgo Intl., Ent., Inc.
Decision Date1988-11-07
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERGO II, SURGICAL LATEX GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Ergo Intl., Ent., Inc.. It received FDA 510(k) clearance on 1988-11-07 under 510(k) number K884030. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO II, SURGICAL LATEX GLOVES?

ERGO II, SURGICAL LATEX GLOVES is a medical device that received FDA 510(k) clearance on 1988-11-07. The listed applicant is Ergo Intl., Ent., Inc.. The 510(k) number is K884030.

When did ERGO II, SURGICAL LATEX GLOVES receive FDA 510(k) clearance?

ERGO II, SURGICAL LATEX GLOVES received FDA 510(k) clearance on 1988-11-07, under 510(k) number K884030.

Who is the listed applicant for ERGO II, SURGICAL LATEX GLOVES?

The FDA 510(k) record lists Ergo Intl., Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERGO II, SURGICAL LATEX GLOVES?

The FDA product code for ERGO II, SURGICAL LATEX GLOVES is KGO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ergo Intl., Ent., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K892166NON-STERILE PATIENT EXAM GLOVES (LATEX)K892026PROLAX PATIENT EXAMINATION GLOVES (LATEX)K892100PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)K892101PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES)

Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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